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.”
The real thing.