25 August 2015 - U.S. health regulators granted priority review status for Sarepta Therapeutics Inc.’s treatment of a rare genetic disorder.

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.

For more details, go to: http://www.wsj.com/articles/fda-grants-priority-review-to-sarepta-drug-candidate-1440541373