FDA panel votes against experimental ALS drug

An FDA advisory committee on March 30 determined there was not enough evidence to endorse Amylyx Pharmaceuticals’ experimental treatment for amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease. 

Advertisement

The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 6-4 that a clinical trial failed to prove the drug is effective in patients with ALS.

The FDA is not required to follow the committee’s recommendations and is expected to make a final decision on the drug’s approval status by June 29.

Editor’s note: This article was updated March 31 at 5:24 p.m.

Advertisement

Next Up in Pharmacy

Advertisement

Comments are closed.