Prognosis
Amylyx Pharmaceuticals’ ALS Drug Wins FDA Approval
- Therapy approved despite lack of certainty of effectiveness
- Drug’s price of $12,500 a month may meet with resistance
The Food And Drug Administration headquarters in White Oak, Maryland.
Photographer: Sarah Silbiger/Getty ImagesThis article is for subscribers only.
Amylyx Pharmaceuticals Inc.’s drug for amyotrophic lateral sclerosis gained US regulatory clearance, but the shares fell as investors were skeptical that the $158,000-a-year treatment will be embraced by payers.
To be called Relyvrio in the US, the therapy won regulatory approval Thursday, making it the third major medicine authorized in the country to slow the disease. It was authorized despite uncertainty about its level of effectiveness in a clinical trial, the Food and Drug Administration said in a statement. The shares fell 4.6% as of 2:42 p.m. Friday in New York.