FDA Approves First New ALS Drug Since 1995

May 08, 2017

The U.S. FDA has approved the first new drug for amyotrophic lateral sclerosis (ALS) in 22 years.

NJ-based Mitsubishi Tanabe Pharma's infusion therapy, Radicava, is just the second treatment for ALS approved in the United States. Sanofi's Rilutek was approved in 1995, and generic versions became available in 2013.

 MT Pharma submitted Radicava for U.S. approval with encouragement from U.S. regulators, following promising late-stage trial results in Japan.

Mitsubishi Tanabe is reportedly seeking a list price of $1,000 per infusion of the drug, which has to be administered by a health care professional via IV. 

Read the press release