$158,000 ALS drug pulled from market after failing in massive medical trial

$158,000 ALS drug pulled from market after failing in large clinical trial

Enlarge (credit score: Amlyx)

Amylyx, the maker of a brand new drug to deal with ALS, is pulling that drug from the market and shedding 70 p.c of its staff after a big medical trial discovered that the drug didn’t assist sufferers, in accordance with an announcement from the corporate Thursday.

The drug, Relyvrio, received approval from the Meals and Drug Administration in September 2022 to sluggish the development of ALS (amyotrophic lateral sclerosis, or Lou Gehrig’s illness). Nonetheless, the information behind the controversial choice was shaky at finest; it was primarily based on a examine of simply 137 sufferers that had a number of weaknesses and questionable statistical significance, and FDA advisors initially voted towards approval. Nonetheless, given the severity of the neurogenerative illness and lack of efficient therapies, the FDA in the end granted approval beneath the situation that the corporate was engaged on a Section III medical trial to solidify its claimed advantages.

Relyvrio—a mix of two current, generic medication—went available on the market with a listing value of $158,000.

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