Snow Postpones DMD Candidate’s Adcom Meeting
A severe snowstorm forecast for the Washington, D.C., area has prompted the FDA to postpone Sarepta’s advisory committee meeting scheduled for last week to discuss its eteplirsen NDA to treat Duchenne muscular dystrophy.
In briefing documents released earlier this week, the FDA said it wanted more evidence of the candidate’s efficacy, as the sponsor’s data were inclusive and potentially skewed.
There is no specific treatment approved for DMD, so Sarepta’s bid is being closely watched. The NDA for eteplirsen is being reviewed under the FDA’s accelerated approval pathway; the PDUFA date is Feb. 26. The agency has not yet set a new date for the advisory committee meeting.