Manufacturer may pull medication from the market following lackluster results from a large trial<\/p>\n<\/h3>\n
By Physician\u2019s Briefing Staff HealthDay Reporter<\/b><\/p>\n
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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.<\/p>\n
“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.”<\/p>\n
Executives added that they were “surprised and disappointed” by the results and would announce their plans for the drug in the next two months.<\/p>\n
Relyvrio was first approved<\/a> 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.<\/p>\n 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<\/a> initially, before being swayed to back it at a follow-up meeting<\/a> 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.<\/p>\n 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<\/a>, despite the questionable data.<\/p>\n