X
Pharma Advancement
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
  • Home
  • Drug Development
    • All
    • Clinical Trials
    • FDA Approvals
    • Research & Development
    development of new antibiotics

    EMA guidance supports development of new antibiotics

    Thermo Fisher Scientific Announces Collaboration with Northeastern University to Advance Biopharmaceutical Characterization and Monitoring Workflows

    Commercial Success In New Biopharmaceutical Innovation Era

    Proteros and AstraZeneca Boost Collaboration Agreement

    Conver to wp

    AbbVie and Cugene Join Forces Concerning Autoimmune Disorders and Cancer

    Drug Imagent For Therapeutic Platform

    Japan Pharma Lobby Says-Price Scheme Is Causing Drug Lag

    Charles River and Valence Discovery Announce Strategic Partnership to Provide Clients with AI-Enabled Drug Design Capabilities

    Charles River and Valo Launch Logica, an Integrated AI-Powered Drug Discovery Solution to Rapidly Deliver Optimized Preclinical Assets

    AstraZeneca announces phase IV ASCENT trial of Tudorza Pressair in patients with COPD meets primary efficacy endpoint

    AstraZeneca announces plans for new strategic R&D centre and Alexion headquarters in Cambridge, Massachusetts

    Lynparza approved in the EU for BRCA-mutated metastatic pancreatic cancer

    Major Success Factors For Clinical Development Organizations

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

    ArisGlobal Expands LifeSphere Clinical Portfolio with Landmark Customer Wins in APAC & Middle East

  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • Events
  • Contact Us
No Result
View All Result
Pharma Advancement
No Result
View All Result
Home Europe

FDA grants Priority Review to Bristol-Myers Squibb and AstraZeneca’s Metreleptin

Yuvraj_pawp by Yuvraj_pawp
5th June 2013
in Europe, News

Bristol-Myers Squibb Company and AstraZeneca announced that the U.S. Food and Drug Administration (FDA) has accepted and granted a Priority Review designation for the Biologics License Application (BLA) for metreleptin, an investigational agent for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy (LD), a rare disease estimated to affect a few thousand people around the world, often with an early age of onset.

“The FDA’s granting of Priority Review for the metreleptin BLA highlights the significant unmet medical need for patients affected by lipodystrophy and brings us an important step closer to potentially bringing a treatment option to these patients,” said Fred Fiedorek, MD, senior vice president, Head of Development, CV and Metabolics at Bristol-Myers Squibb. “Developing metreleptin for the treatment of lipodystrophy demonstrates Bristol-Myers Squibb and AstraZeneca’s continued dedication to scientific innovation and global patient care for people impacted by diabetes and related metabolic disorders.”

The FDA grants Priority Review to medicines that may provide a treatment option where little or no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA aims to complete its review within an eight-month review cycle, rather than the standard 12-month review cycle.

The primary data supporting the BLA filing are from the National Institutes of Health (NIH) ongoing, open-label trial in adult and pediatric patients with inherited or acquired LD.

About the Ongoing National Institutes of Health (NIH) Study

The NIH study is an ongoing, open-label trial of investigational metreleptin in patients with inherited or acquired lipodystrophy. The trial was initiated in 2000 by investigators at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of NIH, to evaluate the safety and efficacy of investigational metreleptin for treating metabolic abnormalities associated with lipodystrophy, including insulin resistance, diabetes mellitus, hypertriglyceridemia and hepatic steatosis and steatohepatitis (also known as fatty liver disease).

About Metreleptin

Metreleptin, an investigational recombinant analog of the human hormone leptin, has received orphan designation from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and is being evaluated for the treatment of metabolic disorders associated with inherited or acquired lipodystrophy.

About Lipodystrophy

Lipodystrophy is a very rare disease estimated to affect only a few thousand people around the world. The condition often presents at an early age during childhood or adolescence.

Patients with lipodystrophy experience a loss of fat tissue, especially fat under the skin. This loss of fat tissue causes a deficit in the hormone leptin. Without enough fat tissue or leptin, the body’s system for regulating energy use and storage falls out of balance. The resulting serious imbalance causes lipid to accumulate where it shouldn’t be found—such as in the liver and muscle—which can lead to serious complications, including severe insulin resistance, diabetes, high levels of triglycerides and/or inflammation in the liver.

There are several reasons for developing lipodystrophy. In some patients, it is genetic and in others it may be acquired for different reasons, including cases in which the immune system may attack and destroy existing fat tissue. Sometimes, clearly defined reasons for the development of the condition are unknown.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to research, develop and commercialize select investigational drugs for type 2 diabetes. The Bristol-Myers Squibb/AstraZeneca collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of diabetes and related metabolic disorders. The expansion of the collaboration covers the co-development and marketing of products in the Amylin Pharmaceuticals portfolio, including, among others, investigational metreleptin, a recombinant analog of the human hormone leptin currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of lipodystrophy.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.

Tags: Europe
Previous Post

Nanotechnology could help fight diabetes

Next Post

Big multiple sclerosis breakthrough

Related Posts

Global Biopharmaceutical Bioseparation Market Eyeing $20bn
Manufacturing

Global Biopharmaceutical Bioseparation Market Eyeing $20bn

4th July 2022
FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters
Manufacturing

FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters

4th July 2022
COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters
Manufacturing

COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters

4th July 2022
Fasenra shows consistent safety and sustained efficacy in long-term Phase III BORA trial in severe eosinophilic asthma
Manufacturing

AstraZeneca Cites Early Lung Cancer Immunotherapy Success

4th July 2022
FDA Experts Recommend Changing COVID Jab Formulation In Fall
Manufacturing

FDA Experts Recommend Changing COVID Jab Formulation In Fall

30th June 2022
Novartis to acquire The Medicines Company for USD 9.7 bn
Manufacturing

Novartis To Slash 8,000 Jobs To Save $1 Billion By 2024

30th June 2022
Next Post

Big multiple sclerosis breakthrough

Latest News

Global Biopharmaceutical Bioseparation Market Eyeing $20bn
Manufacturing

Global Biopharmaceutical Bioseparation Market Eyeing $20bn

4th July 2022
FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters
Manufacturing

FDA Advises Adding Omicron BA.4, 5 To COVID-19 Boosters

4th July 2022
COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters
Manufacturing

COVID-19 Omicron-Specific Vaccines Could Be Used As Boosters

4th July 2022
Fasenra shows consistent safety and sustained efficacy in long-term Phase III BORA trial in severe eosinophilic asthma
Manufacturing

AstraZeneca Cites Early Lung Cancer Immunotherapy Success

4th July 2022
FDA Experts Recommend Changing COVID Jab Formulation In Fall
Manufacturing

FDA Experts Recommend Changing COVID Jab Formulation In Fall

30th June 2022
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.

Qucik Links

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

Resources

  • Advertise with us
  • Contact Us
  • Download Mediapack

System

  • Search
  • Sitemap
  • RSS Feed

© 2017 Copyright © Valuemediaservices 2017 All rights reserved.

No Result
View All Result
  • Home
  • Drug Development
  • Manufacturing
  • Supply Chain
  • Facilities
  • Health & Nutrition
  • 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