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Amylyx’s ALS Drug Relyvrio Fails In PHOENIX Confirmatory Study, Setting Up Withdrawal Question

 
• By Sue Sutter

Company will meet with regulators and the broader ALS community to discuss top-line results and make ‘informed decisions,’ which may include voluntary withdrawal. During FDA review, Amylyx had pledged to remove Relyvrio if PHOENIX failed.

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The failed PHOENIX study was the confirmatory trial for Relyvrio, which was approved based on the smaller, successful CENTAUR study. • Source: Shutterstock

The failure of Amylyx Pharmaceuticals, Inc.’s ALS drug Relyvrio (sodium phenylbutyrate/taurursodiol) in the PHOENIX trial will put the company’s withdrawal pledge to the test in the US.

Key Takeaways
  • During advisory committee review, Amylyx had pledged to withdraw Relyvrio if the PHOENIX trial failed.
  • FDA’s authority to force withdrawal of a product with full approval is little tested, though

On 8 March, Amylyx announced that the 664-patient, Phase III PHOENIX trial in amyotrophic lateral sclerosis failed to reach statistical significance (p=0

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