Manufacturer may pull medication from the market following lackluster results from a large trial
By Physician’s Briefing Staff HealthDay Reporter
MONDAY, March 11, 2024 (HealthDay News) — Amylyx Pharmaceuticals announced Friday that the controversial amyotrophic lateral sclerosis (ALS) drug Relyvrio has failed to help patients in a large follow-up study; however, the company has stopped short of saying it will definitely pull the drug from the market. The drug is sold as Albrioza in Canada.
“Amylyx intends to share plans for Relyvrio/Albrioza in ALS, which may include voluntarily withdrawing Relyvrio/Albrioza from the market,” the company said in its statement. “At this time, Relyvrio/Albrioza and its related patient support program will continue to be available for people living with ALS. Amylyx has voluntarily decided to pause promotion of the medication during this time.”
Executives added that they were “surprised and disappointed” by the results and would announce their plans for the drug in the next two months.
Relyvrio was first approved by the U.S. Food and Drug Administration in September 2022, following a lengthy, impassioned campaign by patients with ALS. Unfortunately, the latest company study showed the drug did not slow the disease compared with a placebo treatment, and it also did not produce improvements on any secondary measures, such as muscle strength.
Relyvrio’s approval was mainly based on results from one small study that was criticized by some FDA scientists. An outside committee of experts also voted against the drug initially, before being swayed to back it at a follow-up meeting requested by patients. At the time, Amylyx noted it was continuing a larger follow-up study of more than 600 patients that would provide further data on the drug.
In a highly unusual move, Amylyx executives at that second advisory committee meeting told FDA regulators they would pull the drug from the market if follow-up research did not confirm its efficacy. That commitment seemed to reassure the FDA advisers, who then voted in favor of the drug’s approval, despite the questionable data.
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