Medicine

STAT+: Amylyx’s case for approval of its ALS drug isn’t ironclad. Here’s why I think it will still happen

This post originally appeared on StatNews.

The odds that Amylyx Pharmaceuticals wins approval from the Food and Drug Administration for Albrioza, its treatment for ALS, have increased significantly over the past two weeks. My prediction: The FDA grants accelerated approval to Albrioza, with the requirement that Amylyx confirm the drug’s benefit for patients with results from the ongoing Phase 3 study — data expected in 2024.

I’m capable of making a positive prediction occasionally. I’m not all doom and gloom. This one feels right, with echoes of how the FDA acted on eteplirsen, the Duchenne muscular dystrophy drug, in 2016, and more recently, Biogen’s Alzheimer’s treatment Aduhelm, in 2021.

Unlock this article by subscribing to STAT+ and enjoy your first 30 days free!

GET STARTED

This post originally appeared on StatNews.