A.L.S. The drug Relyvrio will be withdrawn from the market, according to its manufacturer

Results of a large clinical trial found the treatment worked no better than a placebo.

The maker of the newest approved treatment for amyotrophic lateral sclerosis announced Thursday that it will pull the drug from the market because a large clinical trial failed to produce evidence that the treatment works.

Amylyx Pharmaceuticals said in a statement that it had begun the process of withdrawing the drug in the United States, where it is called Relyvrio, and in Canada, where it is called Albrioza. Starting Thursday, no new patients will be able to start taking the drug, while current patients who wish to continue taking the drug will be able to benefit from a transition program to a free drug program, the company said.

This medication is one of the few treatments for this serious neurological disorder. When the Food and Drug Administration approved it in September 2022, the agency concluded that there was not yet sufficient evidence that the drug could help patients live longer or slow disease progression. .

He still decided to give the drug the green light, instead of waiting two years for the results of a large clinical trial, citing data showing that the treatment was safe and the despair of ALS. the patients. The disease robs patients of their ability to control their muscles, speak and breathe without assistance and often leads to death within two to five years.

Since then , About 4,000 patients in the United States have received the treatment, a powder mixed with water and drunk or ingested through a feeding tube. Its list price was $158,000 per year.

Last month, Amylyx, of Cambridge, Massachusetts, announced that the results of a 48-week trial carrying on 664 patients showed that the treatment did not work better than a placebo. The company then said it would consider removing the drug from the market.

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