FDA Grants Priority Review to Sarepta Drug
Sarepta is developing eteplirsen to treat Duchenne muscular dystrophy, a condition that destroys muscles and frequently kills patients by their 30s. The disease affects roughly one in every 3,500 boys world-wide.
The Food and Drug Administration’s targeted action date on Sarepta’s new drug application is Feb. 26, the company said.
The FDA had previously granted fast-track, orphan drug designation, and rare pediatric disease designation for eteplirsen. Priority review indicates the FDA intends to take action within six months.
The move comes after tension between the regulatory agency led to the resignation of its chief executive, just as the company readied to seek regulatory approval for eteplirsen.
Last month, Sarepta hired Henri Termeer, Genzyme Corp.’s former chief executive, as an adviser to help with its lead drug candidate’s application.
Sarepta shares, which have more than doubled in value this year, have swung wildly as hopes for the drug have risen and fallen. On Tuesday, the stock rose 3.7% to $33.80 in late trading on the Nasdaq Stock Market.
Aug. 25, 2015 6:22 p.m. ET
Write to Maria Armental at [email protected]
Source: Wall Street Journal Health
