FDA again finds Amylyx's ALS data lacking ahead of unusual second adcomm, while stressing dire need for treatments
The FDA’s briefing docs are in ahead of its unusual second adcomm for Amylyx Pharmaceuticals’ experimental ALS drug next week — and the agency’s opinion is largely negative.
While acknowledging that ALS treatments are “desperately needed” and providing an extensive history of their previous flexibility for the disease, FDA reviewers wrote that Amylyx’s submission of new analyses is “not independent data and is simply a new method for analyzing the same survival data presented in the original NDA submission.” The new data packages involve patients who switched over from treatment to placebo after the Phase II trial wrapped up, suggesting better survival results than the study originally indicated.
Keep reading Endpoints with a free subscription
Unlock this story instantly and join 153,900+ biopharma pros reading Endpoints daily — and it's free.