Amylyx Pulls ALS Drugs After Trial Disappointment; FDA Scrutiny Intensifies
April 4, 2024Amylyx Pharmaceuticals has voluntarily withdrawn its ALS drugs Relyvrio and AMX0035 from the US and Canadian markets due to poor trial results.
The withdrawal starts on April 4, with an option for current patients to access a free drug program, while new patients will not receive the drugs.
Following the trial's failure to outperform a placebo, Amylyx is cutting its workforce by 70%.
Despite the FDA's accelerated approval of Relyvrio in 2022, recent findings have cast doubt on the drug's efficacy.
Amylyx is redirecting its efforts towards a new ALS drug and other experimental treatments.
The failed trial has impacted Amylyx's shares and sparked debate over the FDA's approval process and the effectiveness of the drugs.
Advocacy groups, including Public Citizen, support the withdrawal, emphasizing the need for reliable and effective ALS treatments.
Summary based on 12 sources
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Sources
The New York Times • Apr 4, 2024
A.L.S. Drug Relyvrio Will Be Taken Off the Market, Its Maker SaysABC News • Apr 4, 2024
ALS drug will be pulled from US market after study showed patients didn't benefitAP News • Apr 4, 2024
ALS drug will be pulled from US market after study showed patients didn't benefit