logo-loader
viewBiogen Inc

Biogen completes FDA application for muscle wasting drug

Biogen also plans to submit a Marketing Authorization Application to the European Medicines Agency.

Various laboratory testing kits
Spinal muscular atrophy is a serious muscle wasting condition

Biogen Inc (NASDAQ:BIIB) has completed the rolling submission of a New Drug Application (NDA) for its spinal muscular atrophy drug, nusinersen, to the US Food and Drug Administration.

Biogen also plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA).

Spinal muscular atrophy (SMA) is a serious muscle wasting condition caused by the deterioration of nerves cells connecting the brain and the spinal cord to the body’s muscles.

The EMA’s Committee for Medicinal Products for Human Use recently granted “accelerated assessment” to nusinersen, cutting the standard review time.

 Biogen said it will initiate regulatory filings in other regions in the coming months.

“We appreciate the FDA’s collaboration with us during the application process, and we look forward to continuing this productive dialogue, with the goal of rapidly bringing the first treatment for SMA to as many patients as possible.”

Quick facts: Biogen Inc

Price: 301.45 USD

NASDAQ:BIIB
Market: NASDAQ
Market Cap: $49.19 billion
Follow

Add related topics to MyProactive

Create your account: sign up and get ahead on news and events

NO INVESTMENT ADVICE

The Company is a publisher. You understand and agree that no content published on the Site constitutes a recommendation that any particular security, portfolio of securities, transaction, or investment strategy is...

FOR OUR FULL DISCLAIMER CLICK HERE

Watch

Tiziana Life Sciences PLC's chairman discusses the potential for its 'crown...

Tiziana Life Sciences PLC's (LON:TILS)(NASDAQ:TLSA) chairman Gabriele Cerrone tells Proactive London's Andrew Scott why he feels its drug Foralumab is the 'crown jewel' in the company's portfolio. It's a fully-human monoclonal anti-CD3 antibody which is being developed for treatment of...

3 hours, 7 minutes ago

2 min read