Transitioning from Historical to Predictive Demand Forecasting

Traditionally, pharma supply planning relied heavily on historical sales data to project future requirements. While this worked in a more stable market, it often fails to account for the volatility of the modern healthcare landscape. Predictive demand forecasting now incorporates a much broader range of variables, including epidemiological trends, competitor activities, and even social media sentiment. By analyzing these diverse datasets, planners can identify emerging patterns before they manifest as actual orders. This foresight is particularly valuable for launching new drugs, where the initial uptake can be unpredictable. A data-driven approach allows for the rapid adjustment of production schedules, preventing the initial stockouts that can cripple a new therapy’s market entry.

Furthermore, predictive models are increasingly incorporating real-world data from Electronic Health Records (EHRs) and pharmacy claims to gain a more granular understanding of patient behavior. For example, if data shows a rising incidence of a specific condition in a particular geographic region, the supply network can proactively reposition inventory to meet that anticipated need. This “bottom-up” approach to forecasting is far more responsive than traditional “top-down” methods, allowing for a more equitable and timely distribution of medicines. By closing the gap between the point of care and the point of production, pharmaceutical companies can ensure that their operations are truly patient-centric, moving away from a push-based system to a more efficient pull-based model.

The Power of Supply Chain Analytics in Identifying Inefficiencies

Beneath the surface of every global supply network lie hidden bottlenecks and redundant processes that drain resources. Advanced supply chain analytics provides the “x-ray vision” needed to uncover these issues. By mapping every transaction and movement within the system, companies can identify where inventory is sitting idle or where transportation routes are unnecessarily long. This analysis often reveals surprising insights, such as the fact that a small percentage of products may be responsible for a disproportionate amount of logistical cost. Armed with this information, supply chain leaders can reconfigure their networks, perhaps by consolidating distribution centers or switching to more reliable carriers, thereby optimizing the entire value chain.

The application of analytics also extends into the realm of supplier performance and risk assessment. By analyzing the historical performance of hundreds of suppliers, companies can identify which partners are most likely to experience delays or quality issues. This allow for the creation of a “risk-weighted” supplier scorecard, where procurement decisions are based on a balanced view of cost, quality, and reliability. In the event of a global disruption, these analytical tools can quickly simulate various “what-if” scenarios to determine the most effective mitigation strategy. This level of analytical maturity transforms the supply chain from a cost center into a source of strategic insight, enabling the organization to navigate an increasingly complex global environment with confidence and clarity.

Strategies for Global Inventory Optimization

Inventory optimization is a delicate balancing act in the pharmaceutical sector. Holding too much inventory ties up precious capital and increases the risk of product expiration, while holding too little can lead to life-threatening shortages. Data driven pharma supply planning utilizes sophisticated algorithms to determine the “sweet spot” for safety stocks across the entire network. These systems consider factors such as lead-time variability, supplier reliability, and the criticality of the medication. Instead of applying a uniform “30-day supply” rule to all products, companies can now tailor their inventory levels to the specific risk profile of each SKU. This surgical approach reduces waste and frees up capital for investment in research and development.

In addition to safety stock optimization, data-driven strategies are also improving the management of “obsolescence.” By monitoring the expiry dates of products in real-time across the entire distribution network, companies can identify batches that are at risk of expiring before they are used. This allows for proactive redistribution moving products from low-demand areas to high-demand regions where they can be used before they expire. This not only reduces waste but also ensures that valuable medications are not lost due to poor visibility. The integration of “smart labeling” and real-time inventory tracking is making this level of granular management a reality, allowing the pharmaceutical industry to operate with a degree of precision that was previously impossible.

Empowering Leaders to Make Data Driven Decisions

The ultimate goal of any planning system is to provide the intelligence needed for effective leadership. Data driven decisions are inherently more defensible and less prone to the biases that can plague human intuition. In a crisis, such as a sudden geopolitical shift or a natural disaster, leaders who have access to real-time supply chain data can model various “what-if” scenarios to determine the best course of action. They can quickly assess the impact of a plant closure or a port strike and reroute resources accordingly. This agility is a hallmark of a modern pharmaceutical organization, allowing it to maintain operational continuity even when the external environment is in chaos.

Moreover, a data-driven culture fosters a sense of accountability and transparency within the organization. When performance is measured against objective, data-backed KPIs, it is easier to identify areas for improvement and to celebrate successes. It also facilitates better communication with external stakeholders, such as regulatory bodies and investors, who increasingly demand evidence of a robust and well-managed supply chain. By grounding their strategy in data, pharmaceutical leaders can build a more resilient and trustworthy organization, capable of delivering on its promise to patients and shareholders alike. The transition to data-driven decision-making is as much about cultural change as it is about technology, requiring a commitment to curiosity, rigor, and continuous learning.

Integrating Cross-Functional Data for Holistic Planning

For data driven pharma supply planning to reach its full potential, it must break down the barriers between different departments. Logistics data should be integrated with information from clinical development, manufacturing, and commercial teams. For example, if a clinical trial shows exceptionally promising results, the supply planning team should be alerted immediately to begin scaling up production capacity for the eventual launch. Similarly, commercial teams can use supply chain visibility to better manage promotional activities, ensuring that they don’t drive demand for a product that is currently in short supply. This level of cross-functional alignment transforms the supply chain from a back-office function into a strategic driver of business value.

This integration also allows for a more holistic approach to “Sustainability.” By combining logistics data with information on energy consumption and waste production, companies can identify the most effective ways to reduce their environmental impact. They can see how a change in production scheduling or transport mode affects the overall carbon footprint of a product. This data-driven visibility is essential for meeting the increasingly stringent ESG (Environmental, Social, and Governance) targets that are being set by regulators and investors. In this way, data-driven planning is not just about improving efficiency and reliability; it is also about building a more sustainable and responsible industry that can thrive in a resource-constrained world.

As we look toward the next decade, the reliance on data will only increase. The integration of artificial intelligence and machine learning into the planning process will further enhance the accuracy and speed of decision-making. However, the technology is only as good as the data it processes and the people who interpret it. Organizations must prioritize data quality and invest in the analytical skills of their workforce. By building a culture that values evidence over anecdote, the pharmaceutical industry can ensure that its supply networks are as innovative and effective as the therapies they deliver. The path to a more efficient and patient-centric future is paved with data, and those who learn to navigate it will lead the way in global healthcare delivery.

According to the Chief Medical Officer and Head of Global Product Development at Roche, Levi Garraway, MD, PhD, since follicular lymphoma often needs lifelong management, decreasing the burden of care for such individuals is indeed of major importance. Due to this FDA approval, treatment can now be administered in about one minute, which prominently decreases the time patients spend within the clinic and helps to sync care along with their individual requirements as well as preferences.

It is well to be noted that VELO decreases the treatment administration time with an approx. one-minute injection as compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio, which is administered intravenously, Lunsumio VELO by Roche can be administered outpatient and is a fixed-duration treatment that is given for a defined period, and that could be as short as six months. By contrast, treat-to-progression treatment alternatives are designed to be given to patients indefinitely until the time of disease progression or till treatment can no longer be tolerated. Tennessee Oncology and One Oncology’s Dr. Ian Flinn, MD, PhD, says that this approval is a major step when it comes to broadening access to effective treatments for people who are living with follicular lymphoma. Due to its manageable cytokine release syndrome profile as well as decreased administration time, Lunsumio VELO helps oncologists to roll out advanced care across the community practice settings.

Interestingly, the FDA approval has received support from the primary analysis of the GO29781 study, which evaluated Lunsumio VELO across patients having third-line or later (3L+ FL). Inferences showed that the objective response rate as well as the complete response rate within patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively. The median duration when it comes to response was 22.4 months – 95% CI: 16.8–22.8. The most common adverse reactions (≥20%) were the injection site reactions, such as fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, and musculoskeletal pain, as well as diarrhea. Notably, the CRS rate was 30%, and events were mostly low grade, i.e., Grade 1–2 (28%) and Grade 3 (2.1%) occurred in Cycle 1, and all resolved post a median duration of two days (range: 1–15). Apparently, CRS can be severe as well as life-threatening.

It is well to be noted that Lunsumio IV was the first bispecific antibody that was approved for 3L+ FL. Long-term data from the SC as well as IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition. These data have been submitted to other healthcare authorities throughout the world. Recently, the European Commission went on to grant a conditional marketing authorization of Lunsumio SC when it comes to the treatment of adult patients having R/R FL post two or more lines of systemic therapy.

Roche goes on to advance its bispecific antibody programme within the gamut of lymphoma, with ongoing phase III studies assessing Lunsumio and Lunsumio VELO within the earlier lines of treatment. This goes on to include the SUNMO study, which investigates the Lunsumio VELO in combination with Polivy® (polatuzumab vedotin) in the second-line or later large B-cell lymphoma, as well as the MorningLyte study, which investigates the Lunsumio VELO in combination with lenalidomide in past untreated FL.

Boehringer is going to invest $10 billion throughout 2028 to expand its pharmaceutical R&D as well as manufacturing operations within the U.S., including $1 billion that’s dedicated specifically when it comes to capital expenditures. This investment is indeed a part of the broader six-year plan by Boehringer to go ahead and invest $20 billion throughout both its human pharmaceuticals and animal health businesses located in the U.S. The agreement with the U.S. administration exempts Boehringer Ingelheim from potential Section 232 tariffs.

According to Boehringer Ingelheim USA Corporation’s President and CEO, Jean-Michel Boers, Boehringer Ingelheim does have a long history of addressing chronic diseases as well as supporting patients when it comes to their care journey. Almost 70 million Americans are suffering from cardiovascular and renal as well as metabolic diseases, and out of those, 35 million have issues related to chronic kidney disease (CKD). Most are not aware and will not find out that they are suffering from CKD until the damage is done, hence leading to poor health outcomes. He added that they indeed want to thank the President as well as his administration for the constructive engagement to attain those much sought-after lower costs for medicines and also increased investment within the U.S. pharmaceutical sector, all of which would lead to more American jobs. And most significantly, this agreement helps to make sure that the patients get the medicines they require and when they need them.

According to the Chairman of the Boehringer Ingelheim Board of Managing Directors, Shashank Deshpande, this is one of the most powerful investments that any society can make. Every year, they reach millions of people who are living with chronic and interconnected conditions that need integrated care. The voluntary agreement that has been inked indeed strengthens the supply chain when it comes to life-changing medicines, while at the same time reinforcing the foundations when it comes to medical innovation in the U.S. He further added that they must now go ahead and strengthen the resilience as well as sustainability of health systems across the world in order to make sure that pharmaceutical innovation can keep thriving.

Notably, Boehringer is one of the leaders in research and development within the sector, focusing not just on innovative therapies for chronic diseases but also, at the same time, on rare diseases wherein just a few treatment alternatives exist. In the U.S., the footprint of the company goes far beyond the 20 sites across the country, including the manufacturing facilities, R&D centers, and partner locations, as well as U.S. headquarters in both Connecticut for Human Pharma and Georgia when it comes to Animal Health. It is worth noting that almost 8,000 employees are working for Boehringer throughout the U.S.

The partnership, revealed at the AWS re:Invent, is indeed quite a prominent step in terms of the digital transformation of healthcare as well as the life sciences spectrum, which aims to revolutionize clinical trial automation and medical affairs along with analytics by way of an innovative agentic AI platform.

As per the agreement, IQVIA is going to roll out its AI platform on the AWS network in order to elevate scalable, safe as well as intelligent automation throughout the clinical trial execution, medical affairs as well as healthcare analytics. This partnership is designed especially to enhance the clinical trial automation and, at the same time, speed up the trial processes. Additionally, IQVIA as well as AWS are going to explore certain novel opportunities within life science analytics in order to drive the next generation of data-driven insights along with solutions.

As 90% of the largest pharmaceutical companies in the world depend on both IQVIA and AWS in order to power their digital transformation as well as analytics, the companies are indeed committed so as to democratizing AI for life sciences, speeding drug innovation, and also helping with faster delivery related to life-saving treatments for patients across the world.

As per the SVP for Architecture and Standards at IQVIA, Lucas Glass, they are indeed excited to move forward with AWS as being the Preferred Agentic Cloud Provider of IQVIA. Their AI platform looks forward to empowering the life sciences organizations to go ahead and innovate faster and also roll out treatments to patients in a more efficient way. Due to agentic AI, they are going to unlock new possibilities for their clients and also the industry at large.

Director of Global Healthcare and Life Sciences with Amazon Web Services, Allyson Fryhoff, said that they are indeed thrilled to go ahead and support the Agentic AI platform from IOQVIA with a comprehensive breadth of cloud capabilities by AWS. He added that together they aim to help the life sciences sector leverage the power of AI in order to support the ongoing innovation within healthcare and attain outcomes that at one point were perceived to be impossible.

This kind of strategic collaboration goes on to showcase a new era when it comes to agentic AI in life sciences, where the intelligent cloud-powered solutions enable greater efficiency, speed up innovation, and also upgrade the patient outcomes.

The clearance for this single-dose gene replacement therapy gives healthcare teams another way to manage motor-neuron mutation in older children, teens, and adults with confirmed SMA.

The FDA authorisation covers a one-time fixed-dose therapy that replaces the SMN1 gene without any need to adjust for age or body weight. Novartis says the treatment is built to address the underlying genetic cause of SMA by supplying a working copy of the SMN1 gene to help maintain motor-function stability.

The regulatory green light follows results from the open-label Phase IIIb STRENGTH study and the Phase III STEER trial, both of which reported meaningful gains in stabilisation and motor outcomes over 52 weeks. The clinical data also indicated a consistent safety profile. SMA itself stems from a missing or defective SMN1 gene, which disrupts production of SMN protein required for neuromuscular function.

Further programme details show that Itvisma is administered as a single intrathecal injection to sustain SMN protein expression, aligning with durable gene replacement therapy modalities that reduce treatment frequency. Novartis plans to introduce the product in the US market in December 2025.

“After redefining SMA care with the first gene replacement therapy for this challenging disease, we can now help address unmet needs across an even broader SMA population with the approval of Itvisma.” said Novartis US president Victor Bultó. “We are proud to support the SMA community by empowering patients of all ages through our innovative, one-time therapies, offering the potential to reduce the burden that comes with chronic treatment.”

• Merck’s FDA clearance introduces the first PD-1 inhibitor and ADC combination for cisplatin-ineligible MIBC patients, widening its position in the bladder cancer treatment space.
  
• Strong Keynote-905 results may shift perioperative management by elevating the Keytruda–Padcev regimen as a viable alternative to surgery alone.
  
• Intravenous and subcutaneous delivery options give providers more flexibility, which could support broader clinical uptake.

Merck said the US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for use alongside Padcev (enfortumab vedotin-ejfv) as a perioperative regimen for adults with muscle-invasive bladder cancer (MIBC) who cannot receive cisplatin-based chemotherapy.

Under the newly approved approach, patients are treated with Keytruda or Keytruda Qlex combined with Padcev prior to surgery, with therapy resuming after cystectomy. The decision marks the first time a PD-1 inhibitor and antibody-drug conjugate combination has been authorised for this specific patient group.

Regulators issued the approval after reviewing findings from the phase 3 Keynote-905 study, also known as EV-303, which Merck conducted in collaboration with Pfizer and Astellas. In the trial, researchers reported that after a median follow-up of 25.6 months, the combined therapy reduced the risk of event-free survival events by 60% when compared with surgery alone. Investigators also observed a 50% improvement in overall survival, while the pathologic complete response rate reached 57.1% versus 8.6% in the control arm.

The company noted that Keytruda Qlex carries a contraindication for patients with hypersensitivity to berahyaluronidase alfa, hyaluronidase or any of the formulation’s excipients. Merck also highlighted that immune-mediated reactions, potentially severe or fatal, may arise across organ systems. Infusion-related events remain a known risk for both treatments, and the therapies can cause fetal harm if administered during pregnancy.

Commenting on the clinical relevance, Dr Matthew Galsky, Lillian and Howard Stratton Professor of Medicine at Mount Sinai Tisch Cancer Center and Keynote-905 investigator, said: “Pembrolizumab plus enfortumab vedotin is poised to address a critical unmet need. Half of patients with MIBC may experience cancer recurrence even after having their bladder removed, and many of these patients are ineligible to receive cisplatin.”

Dr Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, added: “We are honoured to provide these patients who previously had only one option — surgery — with a choice to receive their immunotherapy either intravenously or subcutaneously.”

“We continue to execute our science-led business development strategy, augmenting our pipeline with CD388, a potentially first-in-class, long-acting antiviral designed to prevent influenza in individuals at higher risk of complications,” said Robert M. Davis, chairman and chief executive officer, Merck. “We intend to build on the Cidara team’s remarkable progress and are confident that CD388 has the potential to be another important driver of growth through the next decade, creating real value for shareholders.”

At the center of the acquisition of Cidara Therapeutics is Cidara’s lead candidate, CD388, which pairs a small molecule neuraminidase inhibitor with a proprietary Fc fragment of a human antibody engineered to prevent influenza A and B. The program is being tested in the Phase 3 ANCHOR study (NCT07159763) involving adult and adolescent participants at elevated risk of influenza-related complications. The U.S. Food and Drug Administration granted Breakthrough Therapy Designation following data from the Phase 2b NAVIGATE study (NCT06609460), which met all primary and secondary endpoints tied to preventing symptomatic laboratory-confirmed influenza in healthy adults ages 18 to 64. CD388 also previously received Fast Track Designation from the FDA.

“This acquisition expands and complements our respiratory portfolio and pipeline. Influenza continues to pose a significant global health threat, causing widespread illness, morbidity and death each year especially in older adults and immunocompromised individuals, such as those with cancer and chronic diseases,” added Dr. Dean Y. Li, president, Merck Research Laboratories. “CD388 is a novel late-phase candidate with important strain-agnostic properties being evaluated for the prevention of symptomatic influenza in high-risk individuals.”

The radioligand therapy manufacturing facility is expected to meet growing demand for RLT while boosting Novartis’ supply chain and production capabilities. The company has filed the site with the FDA as an additional US point of supply, and commercial production can start once it gets approval. RLTs are a type of precision medicine that link a tumor-targeting molecule (ligand) with a therapeutic radioisotope. This approach delivers radiation straight to tumors while sparing nearby healthy cells. Each dose is made to order and extremely time-sensitive because the radioisotope has a short half-life, so being close to treatment centers and transport hubs is essential to get the therapy to patients on time.

“At Novartis, we tackle the toughest challenges in medicine by doing what’s never been done before for patients,” said Vas Narasimhan, CEO of Novartis. “Radioligand therapy is a breakthrough we’ve unlocked at scale, made possible by reimagining how innovation reaches patients. As the global leader in RLT for more than seven years, we’ve advanced this technology with a deep belief in its power to transform cancer care. The opening of our Carlsbad facility underscores our strong commitment to the US and dedication to bringing this pioneering treatment to patients across the country.”

Novartis stands as the only pharmaceutical company with a dedicated commercial RLT portfolio. The radioligand therapy manufacturing site is the company’s third RLT manufacturing facility in the US, reinforcing its leadership in developing, producing, and delivering radioligand therapies worldwide. Purpose-built to produce FDA-approved RLTs, the facility also allows room for future expansion.

“We commend Novartis for supporting our broader mission of bringing manufacturing capacity in the United States,” said FDA Commissioner Marty Makary, M.D., M.P.H.

“Novartis is transforming the future of cancer care—and it’s happening right here in Carlsbad,” said Carlsbad City Council Member Melanie Burkholder. “This new advanced RLT production facility is a major milestone for our region, strengthening California’s position as a hub for life sciences innovation. It will bring exciting new opportunities for our community, including more engineering and manufacturing jobs. I’m proud our local community will be part of the future of cancer care.”

Beyond Carlsbad, Novartis is pursuing multiple initiatives across the US. These include two additional RLT manufacturing sites in Florida and Texas, expansions at existing sites in Durham, North Carolina, Indianapolis, Indiana, and Millburn, New Jersey, and the creation of a second global R&D hub in the US with a new biomedical research innovation center in San Diego, California.

Backed by a supportive regulatory environment, these projects show Novartis’ strong commitment to the US healthcare system. The company expects to invest nearly $50 billion in its US operations over the next five years, including the $23 billion announced earlier, underlining its long-term commitment to innovation and building out infrastructure.

“Lilly’s mission is to make life better for people around the world, and today that requires excellence not just in science but also in technology,” said Diogo Rau, executive vice president and chief information and digital officer at Lilly. “I don’t believe any other company in our industry is doing what we do at this scale. As a 150-year-old medicine company, one of our most powerful assets is decades of data. With purpose-built AI models and AI, we can set a new scientific standard that accelerates innovation to deliver medicines to more patients, faster.”

The new supercomputer for drug research will be the world’s first NVIDIA DGX SuperPOD equipped with DGX B300 systems. It incorporates more than 1,000 B300 GPUs operating on a unified high-speed network that connects computing, storage, and supporting systems on a single communication framework.

The setup is meant to change the way Lilly’s scientists handle large-scale research, making it easier to test and refine AI models quickly. This supercomputer for drug research will let them run experiments across millions of data points and open up more possibilities for discovering new drugs. Proprietary AI models will also be made available through Lilly TuneLab, a federated AI/ML drug discovery platform intended to enhance collaboration within the biopharma sector. TuneLab’s offerings will continue to evolve with additional tools and selected NVIDIA Clara open-source models.

Beyond early-stage research, Lilly intends to use the supercomputer to shorten development timelines and accelerate delivery of new treatments. AI agents will assist researchers with reasoning, planning, and collaboration across digital and physical spaces. Advanced medical imaging will provide deeper insight into disease mechanisms and support the creation of new biomarkers for personalized medicine. In manufacturing, digital twins and NVIDIA’s robotic technologies will help streamline production processes, improving efficiency and reducing downtime.

“The AI industrial revolution will have its most profound impact on medicine, transforming how we understand biology,” said Kimberly Powell, vice president of health care at NVIDIA. “Modern AI factories are becoming the new instrument of science — enabling the shift from trial-and-error discovery to a more intentional design of medicines. With its deep scientific heritage and commitment to innovation, Lilly stands as a global leader at the forefront of this new era of medical discovery.”

“Lilly is shifting from using AI as a tool to embracing it as a scientific collaborator,” added Thomas Fuchs, senior vice president and chief AI officer at Lilly.  “By embedding intelligence into every layer of our workflows, we’re opening the door to a new kind of enterprise: one that learns, adapts and improves with every data point. This isn’t just about speed, but rather interrogating biology at scale, deepening our understanding of disease and translating that knowledge into meaningful advances for people served by Lilly medicines as well as the broader life sciences ecosystem.”

Aligned with the company’s sustainability goals, including achieving carbon neutrality by 2030, the supercomputer will operate entirely on renewable electricity within existing Lilly facilities. It will also utilize the company’s chilled water system for efficient liquid cooling. Lilly will present further details of its “Enterprise-Scale AI for Drug Discovery: Strategy, Infrastructure and Outcomes,” at NVIDIA’s AI conference GTC in Washington, D.C.

“In clinical practice, we see that simplifying maintenance treatment can make a difference in the overall patient experience,” said Miguel Regueiro, M.D., a board-certified gastroenterologist specializing in inflammatory bowel disease. “A single monthly injection of Omvoh gives patients a regimen that’s easier to manage alongside the unpredictability of living with ulcerative colitis.”

The newly approved citrate-free, single-injection formulation of Omvoh will be made available in the United States by early 2026 through either a prefilled pen or prefilled syringe. The U.S. decision comes shortly after the European Union’s authorization of Omvoh for the same single-injection maintenance use in ulcerative colitis patients.

“People living with the constant discomfort and disruption caused by the symptoms of ulcerative colitis need treatments that offer the potential to achieve lasting remission and a convenient dosing option that fits easily into their lives,” said George Salem, M.D., director of the Crohn’s and Colitis Center at OU HEALTH. “With this approval, patients who respond to induction therapy with Omvoh can continue maintenance therapy with the convenience of just one injection each month — delivering the same proven results with fewer injections.”

The FDA’s approval follows a Phase 1 study comparing one 200 mg/2 mL subcutaneous injection to two 100 mg/1 mL injections in patients. The study established that the single-injection dose is bioequivalent to the earlier two-injection regimen. Treatment with Omvoh begins with three 300-mg IV infusions given every four weeks before transitioning to a subcutaneous self-injection every four weeks at Week 12 for ongoing maintenance.

“At Lilly, we are committed to supporting people living with IBD by delivering meaningful clinical outcomes and continuing to improve their treatment experience,” said Ashley Diaz-Granados, senior vice president of U.S. Immunology at Lilly. “Building on the introduction of a citrate-free formulation of Omvoh earlier this year, this approval further delivers on our commitment by providing patients the same outcomes in a single-injection maintenance regimen that fits more seamlessly into their lives.”

Omvoh is currently approved in the United States for treating moderately to severely active ulcerative colitis and Crohn’s disease in adults, and it has received regulatory approval in 45 countries worldwide. Lilly also offers patient assistance through Lilly Support Services™, including co-pay support for eligible, commercially insured patients.