FDA delays high-stakes decision on muscular dystrophy drug
WASHINGTON - Federal health regulators will take more time to review a highly-contested drug for muscular dystrophy that has become a flashpoint in the debate over patient access to experimental medicine.
Drugmaker Sarepta Therapeutics Inc. said the Food and Drug Administration will miss its goal of issuing a decision on the drug by Thursday. While the FDA does not comment on such delays, the extended timeline raises the possibility that regulators may ultimately approve the company's medication.
Company shares rocketed 16 percent higher in morning trading.
Sarepta's drug eteplirsen has become rallying point for patients and families stricken by the deadly inherited disease, which causes muscle weakness and eventually the loss of all basic movement. The disease affects one of every 3,600 boys worldwide and usually causes death by age 25.