Corporate Banner
Satellite Banner
Medicinal Chemistry
Scientific Community
Become a Member | Sign in
Home>News>This Article

GENFIT: The FDA Grants Fast Track Designation to GFT505 in NASH

Published: Tuesday, February 18, 2014
Last Updated: Tuesday, February 18, 2014
Bookmark and Share
Granting accelerate the development of GFT505 and reduce the time to market.

GENFIT has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to the GFT505 development program in NASH, with effect from February 14, 2014.

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs.

The aim is to ensure that new therapies for serious conditions are approved and available to patients as soon as possible. This designation permits close and regular contact between GENFIT and the FDA, thus enabling the joint definition of the most efficient development plan through frequent meetings and an accelerated review process.

GENFIT is currently conducting the Phase IIb study GFT505-212-7, for which the primary objective is to demonstrate the efficacy of one year of treatment with GFT505 (80 mg/d and 120 mg/d versus placebo) on the reversion of biopsy-diagnosed NASH. This international study involves a total of 56 centers of clinical excellence in the United States and in multiple European countries.

All patients (a total of 270) have been recruited, more than half have been under treatment for more than 6 months, and the first patients have completed one year of treatment. The results should be announced at the end of 2014.

Commenting on the FDA’s Fast Track designation for GFT505, Jean-François MOUNEY, Chairman and Chief Executive Officer of GENFIT, declared: «All the preclinical and clinical data obtained to date show that GFT505 has the ideal profile for NASH treatment. The granting of the Fast Track designation will enable us to accelerate the development of GFT505 and reduce the time to market.»

Further Information
Access to this exclusive content is for Technology Networks Premium members only.

Join Technology Networks Premium for free access to:

  • Exclusive articles
  • Presentations from international conferences
  • Over 2,800+ scientific posters on ePosters
  • More than 4,000+ scientific videos on LabTube
  • 35 community eNewsletters

Sign In

Forgotten your details? Click Here
If you are not a member you can join here

*Please note: By logging into you agree to accept the use of cookies. To find out more about the cookies we use and how to delete them, see our privacy policy.

Scientific News
Drug May Prevent Life-Threatening Muscle Loss in Advanced Cancers
New data describes how an experimental drug can stop life-threatening muscle wasting (cachexia) associated with advanced cancers and restore muscle health.
Chemical Design Made Easier
Rice University scientists prepare elusive organocatalysts for drug and fine chemical synthesis.
Nanocarriers May Carry New Hope for Brain Cancer Therapy
Berkeley lab researchers develop nanoparticles that can carry therapeutics across the brain blood barrier.
Potential Persistent Tuberculosis Treatment
Researchers have discovered several first-in-class compounds that target hidden TB infections by attacking a critical process the bacteria use to survive in the hostile environment of the lungs.
Shedding Light on “Dark” Cellular Receptors
UNC and UCSF labs create a new research tool to find homes for two orphan cell-surface receptors, a crucial step toward finding better therapeutics and causes of drug side effects.
Giant Molecules Inhibit Ebola Infection
European researchers have designed a "giant" molecule formed by thirteen fullerenes covered by carbohydrates which, by blocking this receptor, are able to inhibit the cell infection by an artificial ebola virus model.
First Therapy Appearing to Reverse Decline in Parkinson’s
An FDA-approved drug for leukemia improved cognition, motor skills and non-motor function in patients with Parkinson’s disease and Lewy body dementia in a small clinical trial, say researchers at Georgetown University Medical Center (GUMC).
Fighting Pain with Ketamine
Researchers at the Texas A&M Health Science Center are using ketamine, a drug that already exists as an anesthetic, to treat pain.
Possible New Treatment for Neurodegenerative Diseases Found
Researchers at the University of Liverpool have found that a well-established anti-epileptic drug could also be used as a treatment for neurodegenerative diseases.
Breast Cancer Drug Beats Superbug
Tamoxifen helps white blood cells clear multidrug-resistant bacteria in lab and mouse studies.
Skyscraper Banner

SELECTBIO Market Reports
Go to LabTube
Go to eposters
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
2,800+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,000+ scientific videos