Amylyx Pharmaceuticals will take its ALS drug Relyvrio off the market in the U.S. and Canada, ending a multi-year saga for patients with the rare neurodegenerative disease.
Relyvrio was approved by the Food and Drug Administration in 2022, based on data that showed a modest slowing of disease progression. The approval was contentious — regulators initially advised Amylyx not to file for approval until it had conducted another test, but ultimately cleared the drug. Amylyx’s co-CEOs Joshua Cohen and Justin Klee also publicly promised that they would withdraw the drug if further testing failed to show a benefit.
That exact scenario came to bear last month, when Amylyx announced that a Phase 3 study involving 664 people failed.
This article is exclusive to STAT+ subscribers
Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
