A large clinical trial found that Amylyx Pharmaceuticals’ drug to treat ALS doesn’t work, raising questions about the FDA’s process for approving it.
The FDA headquarters in Silver Spring, Md. The agency has used a flexible approach in recent years to approve drugs for particularly devastating conditions. Justin Klee and Josh Cohen had pulled off an improbable success, turning an idea they hashed out as undergraduates into a drug that aimed to slow one of the world’s most implacable and deadly neurological diseases.On the strength of a single clinical trial, they’d won U.S.
“The FDA recognizes there is a substantial unmet medical need for safe and effective treatments for ALS, as there is for so many of the devastating neurological diseases,” the agency said in a statement. “All our decisions are guided by science and exhaustive review of the data in any application,” including Relyvrio, it said.
Klee and Cohen, for their part, said they’ve met many people diagnosed with ALS in their 30s with young kids, contending that withholding a treatment that could buy them more time would be wrong. In March 2022, a committee of outside experts who advise the FDA voted 6-4 that Amylyx lacked evidence that its drug worked. The agency’s staff also found that the study’s positive result “was not exceptionally persuasive,” and expressed other concerns with the company’s analysis.
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