FDA approves new Duchenne's muscular dystrophy drug

Marathon Pharmaceuticals earned approval from the Food and Drug Administration for its drug Emflaza.

Emflaza is intended to treat Duchenne's muscular dystrophy, a rare degenerative condition that causes muscle weakness, loss of movement and eventually death.

The drug represents the first corticosteroid approved as a treatment for DMD and the second FDA-approved treatment overall behind Sarepta Therapeutics' Exondys 51, which was approved in September.

Northbrook, Ill.-based Marathon Pharmaceuticals earned a fast track designation and priority review status for the drug, both of which accelerate the FDA's review process to bring drugs to the market faster. Emflaza also earned an orphan drug designation, which offers drugmakers incentives to assist and encourage the development of rare disease treatments.

More articles on supply chain:

Supply chain tip of the week: 9 questions to test your inventory management IQ
10 statistics on drug, device recalls in Q4
6 quotes from Pfizer CEO on Trump, drug prices and more

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars