The FDA’s Roller Coaster Ride for DMD Families

For months, the Duchenne community expected eteplirsen and drisapersen to be reviewed by an Advisory Committee on back-to-back days in November 2015. Now the FDA has delayed eteplirsen again until next year. This is unacceptable. The Race to Yes and patient advocacy organizations sent an urgent letter to the FDA demanding answers. As of November 2015, they have received no reply. Another advisory committee meeting has been scheduled for January 22, 2016, but the FDA has not confirmed that Sarepta’s drug will be reviewed that day.

Download the Letter