Amylyx to swipe ALS from market after study failure

Amylyx Pharmaceuticals is withdrawing its FDA-approved therapy for amyotrophic lateral sclerosis, Relyvrio, from the market after a phase 3 study failure, the company said April 4. 

In early March, the Cambridge, Mass.-based drugmaker said a 48-week study involving 664 ALS patients found the drug was safe and well-tolerated, but the clinical trial did not confirm overall efficacy. The FDA approved the therapy in September 2022, and Amylyx is working with officials in the U.S. and Canada to voluntarily discontinue the drug. 

After discussing the results with advocacy organizations, patients, caregivers and global experts, Amylyx said patients who wish to stay on the treatment can do so for free after consulting with their physicians.

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