The maker of a drug for Lou Gehrig’s disease that recently failed in a study says it will pull the medicine from the U.S. market. Amylyx Pharmaceuticals said Thursday it will halt marketing in the U.S. and Canada. In March, the drugmaker announced that its drug had failed to show any benefit for patients in a 600-person study. The drug’s failure is a major disappointment for ALS patients and advocates who pressed the FDA to approve it. Amylyx's voluntary withdrawal resolves a potential dilemma for the FDA, which had no way of quickly forcing the drug from the U.S. market. That's because regulators granted the drug full approval in 2022, despite the Cambridge, Massachusetts, company presenting only preliminary study results.
The maker of a drug for Lou Gehrig’s disease that recently failed in a study says it will pull the medicine from the U.S. market. Amylyx Pharmaceuticals said Thursday it will halt marketing in the U.S. and Canada. In March, the drugmaker announced that its drug had failed to show any benefit for patients in a 600-person study. The drug’s failure is a major disappointment for ALS patients and advocates who pressed the FDA to approve it. Amylyx's voluntary withdrawal resolves a potential dilemma for the FDA, which had no way of quickly forcing the drug from the U.S. market. That's because regulators granted the drug full approval in 2022, despite the Cambridge, Massachusetts, company presenting only preliminary study results.
ALS Drug Will Be Pulled From US Market After Study Showed Patients Didn t Benefit usnews.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from usnews.com Daily Mail and Mail on Sunday newspapers.
Relyvrio's withdrawal leaves just three ALS medicines available to U.S. patients, only one of which has been shown to extend survival by several months.
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