FDA nod for new ALS treatment option

The US Food and Drug Administration yesterday approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease.

The FDA had granted this application from US drugmaker Amylyx Pharmaceuticals (Nasdaq: AMLX) priority review. Amylyx shares edged up 3.3% by close of trading yesterday and a further 9.3% to $33.01 after-hours.

The approval is seen as a victory for patients and advocates despite limited evidence that the drug is effective. In a second advisory committee review, a favorable vote came despite yet another poor review from FDA experts.