FDA delays high-stakes decision on muscular dystrophy drug

WASHINGTON (AP) — 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.

WIVB.com provides commenting to allow for constructive discussion on the stories we cover. In order to comment here, you acknowledge you have read and agreed to our Terms of Service. Commenters who violate these terms, including use of vulgar language or racial slurs, will be banned. Please be respectful of the opinions of others. If you see an inappropriate comment, please flag it for our moderators to review. Note: Comments containing links are not allowed.

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s