S

arepta Therapeutics will file an application with the Food and Drug Administration by the end of 2018 seeking accelerated approval for its second drug to treat Duchenne muscular dystrophy, a rare, inherited, muscle-wasting disease.

In an announcement Monday, the company, based in Cambridge, Mass., said the decision to seek a rapid approval of its drug, called golodirsen, was made after receiving a report last week that summarized a meeting with FDA officials held in February.

Unlock this article by subscribing to STAT Plus today. Try it FREE for 30 days and cancel anytime!

SUBSCRIBE TODAY

What is it?

STAT Plus is a premium subscription that delivers daily market-moving biopharma coverage and in-depth science reporting from a team with decades of industry experience.

What's included?

  • Authoritative biopharma coverage and analysis, interviews with industry pioneers, policy analysis, and first looks at cutting edge laboratories and early stage research
  • Subscriber-only networking events and panel discussions across the country
  • Monthly subscriber-only live chats with our reporters and experts in the field
  • Discounted tickets to industry events and early-bird access to industry reports

Leave a Comment

Please enter your name.
Please enter a comment.

Sign up for our Morning Rounds newsletter

Your daily dose of what’s new in health and medicine.

Privacy Policy