Relyvrio, which costs $158,000 annually, was approved by the FDA in September 2022 despite controversy over limited data supporting its effectiveness. The initial approval was based on a small, flawed study in 137 patients, and FDA advisors initially voted against it. However, the lack of treatment options for ALS, a debilitating and progressive neurodegenerative disease, led to conditional approval requiring a phase III confirmatory study.
This larger study, involving 664 patients, ended last month with disappointing news for ALS patients and Amylyx. Relyvrio did not show improvements in physical function, quality of life, respiratory function, or overall survival compared with placebo.
Calling this a “difficult moment for the ALS community,” Amylyx announced that it was withdrawing the drug from the market but would continue its program to provide the drug for free to existing patients. New patients will no longer have access to Relyvrio.
The company is undergoing a major restructuring, laying off 70% of its workforce (more than 350 employees) to focus on developing drugs to treat other neurodegenerative diseases.
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Source: Ferra
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