that recently failed in a large study said Thursday it will pull the medicine from the market, acknowledging it didn't help patients with the deadly neurological condition.Amylyx Pharmaceuticals announced it will voluntarily halt sales and marketing of the drug in the U.S. and Canada, where new patients will no longer be able to get a prescription.
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. The company's voluntary action resolves what could have been a major dilemma for the FDA. The agency's regulators would not have had a clear path to quickly force the drug from the market if the company had refused to remove it. That's because the FDA granted the drug full approval, despite the preliminary nature of the company's data on effectiveness.
The medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable evidence they work.
Belgique Dernières Nouvelles, Belgique Actualités
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