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FDA Moves Review of Sarepta’s Eteplirsen to April 25

March 16, 2016

The FDA has pushed the much-anticipated advisory committee review of Sarepta’s eteplirsen to April 25.

Originally scheduled for Jan. 22, the meeting of the Peripheral and Central Nervous System Drugs Advisory Committee was cancelled due to inclement weather. In briefing documents posted ahead of the January meeting, the FDA asked for more evidence to solidify the candidate’s efficacy in treating Duchenne muscular dystrophy, as the sponsor’s data were possibly skewed.  

The FDA had similar concerns with BioMarin’s DMD candidate Kyndrisa.