Amylyx Pulls ALS Drugs After Trial Disappointment; FDA Scrutiny Intensifies

April 4, 2024
Amylyx Pulls ALS Drugs After Trial Disappointment; FDA Scrutiny Intensifies
  • Amylyx Pharmaceuticals has voluntarily withdrawn its ALS drugs Relyvrio and AMX0035 from the US and Canadian markets due to poor trial results.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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