X
Pharma Advancement
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    FDA Accepts BLA for Recommended

    FDA Accepts BLA for Recommended Biosimilar to Simponi

    Merck to Acquire Verona

    Merck to Acquire Verona Pharma in $10B Deal Boosts COPD Drug

    Emerging Oral Small Molecule Drugs

    Emerging Oral Small-Molecule Drugs for Ultra-Rare Diseases

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    Avadel Pharmaceuticals Receives

    Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

    Robots and AI in Drug

    Robots and AI in Drug Discovery Are Transforming Medicine

    Stringent Policy around COVID Vaccines Laid by FDA

    Stringent Policy around COVID Vaccines Laid by FDA

    Pharmaceutical-Chemicals Market Booms with Rising API Demand

    Pharmaceutical Chemicals Market Booms with Rising API Demand

    Next in Pharma 2025 Innovations

    Next in Pharma 2025: Innovations Shaping the Future

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Articles
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    FDA Accepts BLA for Recommended

    FDA Accepts BLA for Recommended Biosimilar to Simponi

    Merck to Acquire Verona

    Merck to Acquire Verona Pharma in $10B Deal Boosts COPD Drug

    Emerging Oral Small Molecule Drugs

    Emerging Oral Small-Molecule Drugs for Ultra-Rare Diseases

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    FDA Approves Oral Therapy for Treating Hereditary Angioedema

    Avadel Pharmaceuticals Receives

    Avadel Pharmaceuticals Receives Orphan Drug Designation from FDA for LUMRYZ™ (sodium oxybate) for Extended-Release Oral Suspension for the Treatment of Idiopathic Hypersomnia

    Robots and AI in Drug

    Robots and AI in Drug Discovery Are Transforming Medicine

    Stringent Policy around COVID Vaccines Laid by FDA

    Stringent Policy around COVID Vaccines Laid by FDA

    Pharmaceutical-Chemicals Market Booms with Rising API Demand

    Pharmaceutical Chemicals Market Booms with Rising API Demand

    Next in Pharma 2025 Innovations

    Next in Pharma 2025: Innovations Shaping the Future

  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Drug Development FDA Approvals

US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

Content Team by Content Team
8th February 2019
in FDA Approvals, News
US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

Note* - All images used are for editorial and illustrative purposes only and may not originate from the original news provider or associated company.

AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US FDA has granted Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.

A BTD is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines. MEDI8897 is being developed in partnership with Sanofi Pasteur and received Fast Track designation from the US FDA in March 2015.

Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, said: “MEDI8897 is our next-generation preventive medicine for respiratory syncytial virus, which has the potential to address an important unmet need for infants, families and caregivers. The Breakthrough Therapy Designation, together with its recent PRIME eligibility from the European Medicines Agency, will help us to bring MEDI8897 to all infants at risk for RSV as quickly as possible.”

The BTD is based on the primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, which met its primary endpoint defined as a statistically-significant reduction in the incidence of medically-attended LRTI caused by reverse transcriptase polymerase chain reaction-confirmed RSV, for 150 days after dosing in healthy preterm infants. Full results from the Phase IIb trial will be presented at a forthcoming medical meeting.

About MEDI8897
MEDI8897 is an extended half-life RSV F mAb being developed for the prevention of LRTI caused by RSV. MEDI8897 is being developed for use in a broader infant population than the current standard of care for RSV prevention, Synagis (palivizumab), which in the US is only approved for use in high-risk infants. Additionally, MEDI8897 is being developed so that it may only require one dose during a typical five-month RSV season, vs. monthly injections with current standard of care.1

The development programme for MEDI8897 also includes a Phase III trial in late preterm and healthy full-term infants. AstraZeneca will also conduct a Phase II/III study in Synagis-eligible paediatric patients to generate additional data for use in this population.

In February 2019, the EMA granted PRIME eligibility to MEDI8897.

In March 2017, AstraZeneca and Sanofi Pasteur announced an agreement to develop and commercialise MEDI8897 jointly. In November 2018, AstraZeneca announced Swedish Orphan Biovitrum AB (publ) (Sobi) has the right to participate in payments that may be received from the US profits or losses for MEDI8897.

About RS
RSV is the most common cause of LRTI in infants and young children worldwide, and 90% of children are infected with RSV in the first two years of life. Of those, up to 40% will experience a LRTI with the initial episode, making the development and availability of effective prevention methods a critical public health priority.2 In the US, there is currently one approved medicine for RSV prophylaxis, Synagis (palivizumab), indicated for high-risk children (premature infants ≤ 35 weeks gestational age, children with chronic lung disease of prematurity, and children with haemodynamically significant chronic heart disease).3

About MedImmune
MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular, Renal and Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK and South San Francisco, CA. For more information, please visit www.medimmune.com

About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Previous Post

Solentim and ATUM announce technology collaboration to enable rapid, high expression, stable cell line development

Next Post

Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China

Related Posts

FDA Accepts BLA for Recommended
FDA Approvals

FDA Accepts BLA for Recommended Biosimilar to Simponi

22nd July 2025
Merck to Acquire Verona
Drug Development

Merck to Acquire Verona Pharma in $10B Deal Boosts COPD Drug

21st July 2025
ChiRhoClin LogiCare3PL Partners for Drug Distribution
News

ChiRhoClin, LogiCare3PL Partners for Drug Distribution

21st July 2025
Thermo Fisher and Sanofi Partners
Manufacturing

Thermo Fisher and Sanofi Partners for US Drug Manufacturing

21st July 2025
EMA Recommendations to Secure Anti D Immunoglobulins Supply
News

EMA Recommendations to Secure Anti-D Immunoglobulins Supply

15th July 2025
FDA Approves Oral Therapy for Treating Hereditary Angioedema
FDA Approvals

FDA Approves Oral Therapy for Treating Hereditary Angioedema

15th July 2025
Next Post
Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China

Samsung Bioepis and C-Bridge Capital to Develop and Commercialize Next-Generation Biosimilars in China

Qucik Links

  • Drug Development
  • Manufacturing
  • News
  • Events & Conferences
  • Newsletter Archive
Pharma Advancement

About Us

Pharma Advancement is a leading Pharma information centric website. On one side Pharmaadvancement.com has established itself as one of the most efficient and comprehensive source of Pharma information online, dedicated to providing decision makers in all the Pharma industry sectors with reliable, accurate and useful insights into happenings in the Pharma sector.

Subscribe Us

System

  • Search
  • Sitemap
  • RSS Feed

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack
  • Newsletters Archive

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Articles
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Insights
  • Events
  • Contact Us

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

Login to your account below

Forgotten Password?

Fill the forms bellow to register

All fields are required. Log In

Retrieve your password

Please enter your username or email address to reset your password.

Log In