Sarepta's Duchenne Drug Gains New Panel Review Date, Maybe Optimism
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA reschedules eteplirsen's advisory committee meeting for April 25.
You may also be interested in...
Sarepta's Eteplirsen Is Centerpiece Of Senate Hearing On Expanded Access
Witnesses call for political pressure on FDA to approve the Duchenne drug; patients and advocates also urge general approval reciprocity with Europe and incentives for pediatric trials; agency was not invited to testify.
BioMarin's Drisapersen 'Compete Response' Shows FDA Flexibility Still Limited
FDA wants another clinical trial for Duchenne muscular dystrophy treatment; focus moves to Sarepta's candidate, which gets committee review next week.
Drisapersen Advisory Committee Is Rough Welcome To FDA For Patient Groups
Advocates counter FDA’s problems with Duchenne muscular dystrophy treatment's trial data using real-life experience.