The maker of a drug for Lou Gehrig's disease that recently failed in a large study said Thursday it will pull the medicine from the market, per the AP. Amylyx Pharmaceuticals announced it will voluntarily halt sales and marketing of Relyvrio in the US and Canada, where new patients will no longer be able to get a prescription. "While this is a difficult moment for the ALS community, we reached this path forward in partnership with the stakeholders who will be impacted and in line with our steadfast commitment to people living with ALS," company co-founders said in a statement. Patients already taking the therapy who wish to continue will be able to enroll in a program to receive it for free. Amylyx had faced criticism for pricing the drug at $158,000 for a year's supply.
The FDA approved Relyvrio in September 2022, following a years-long campaign by patients with ALS. The drug's failure is a bitter disappointment for patients and advocates, who have pressed the FDA and other federal agencies to fund and approve more experimental therapies for the fatal muscle-wasting disease. Relyvrio's withdrawal leaves just three ALS medicines available to US patients, only one of which has been shown to extend survival by several months. Amylyx also said Thursday it will lay off 70% of its more than 350 employees as part of a major restructuring. Amylyx said last month it was considering pulling its drug after a clinical trial in 600 patients failed to show any improvements in survival or health measures, such as muscle strength or walking ability.
The company's voluntary action resolves what could have been a dilemma for the FDA. The agency's regulators would not have had a clear path to quickly force the drug from the market, because the FDA granted the drug full approval, despite the preliminary nature of the company's data. The 2022 approval was mainly based on results from one small, mid-stage study that was criticized by some of the agency's own scientists. At the time FDA officials explained that "regulatory flexibility" was appropriate, "given the serious and life-threatening nature of ALS and the substantial unmet need." The medication is part of a string of drugs for deadly, degenerative diseases that have won FDA approval in recent years despite questionable evidence they work. (More Lou Gehrig's disease stories.)
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