Acceleron Pharma Receives FDA Fast Track Designation for ACE-031 for the Treatment of Duchenne Muscular Dystrophy

CAMBRIDGE, Mass. - (Business Wire) Acceleron Pharma, Inc., a biopharmaceutical company developing novel therapeutics that modulate the growth of cells and tissues including muscle, bone, fat, red blood cells and the vasculature, today announced it received FDA Fast Track designation for ACE-031 for the treatment of Duchenne Muscular Dystrophy (DMD), a fatal neuromuscular disease in which patients suffer from the progressive loss of muscle mass and strength. ACE-031 is an investigational protein therapeutic being developed to increase muscle mass and strength.

The Fast Track program of the FDA 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. Fast Track designated drugs typically qualify for priority review which can further expedite the FDA review process.

“Acceleron is working diligently to develop ACE-031 for patients suffering from DMD,” said Matthew Sherman, M.D., Chief Medical Officer at Acceleron. “We are pleased the FDA recognizes the potential of ACE-031 to address the enormous unmet medical need for therapeutics to treat DMD patients. We will continue to work collaboratively with clinical investigators, health authorities and patient advocacy groups around the world to develop ACE-031.”

Views: 71

Reply to This

Replies to This Discussion

Very good news,could we have more info!

Thanks Raktim. This release helps me walk with better balance since the recent utrophin news.
Do you think that ACE 031 is going to work based on this news?
I am from London ON where this trial is ongoing.
Is Losartan effective in stopping the decline of muscles in DMD?

Thank you very much
what does an FDA fast track mean in a drug that is only being tested in canada?
That's what I was wondering too Jenn. Exactically how does FDA define Fast Track, what does that mean for us here in the usa?
Yes, it really does sound fine Juan. Thanks for posting this!


Reply to Discussion


Need help using this community site? Visit Ning's Help Page.



© 2020   Created by PPMD.   Powered by

Badges  |  Report an Issue  |  Privacy Policy  |  Terms of Service