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The maker of a drug for Lou Gehrig\u2019s disease that recently\u00a0failed in a large study<\/a>\u00a0said Thursday it will pull the medicine from the market, acknowledging it didn\u2019t help patients with the deadly neurological condition.<\/p>\n Amylyx Pharmaceuticals announced it will voluntarily halt sales and marketing of the drug in the U.S. and Canada, where new patients will no longer be able to get a prescription.<\/p>\n \u201cWhile 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,\u201d company executives 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.<\/p>\n The Food and Drug Administration approved the much-debated drug, Relyvrio, in September 2022, following a\u00a0years-long advocacy campaign<\/a>\u00a0by patients with amyotrophic lateral sclerosis, or ALS.<\/p>\n The drug\u2019s failure is a bitter disappointment for patients and advocates, who have\u00a0pressed the FDA and other federal agencies<\/a>\u00a0to fund and approve more experimental therapies for the fatal muscle-wasting disease.<\/p>\n Relyvrio\u2019s withdrawal leaves just three\u00a0ALS medicines<\/a>\u00a0available to U.S. patients, only one of which has been shown to extend survival by several months.<\/p>\n Cambridge, Massachusetts-based Amylyx said in March it was considering pulling its drug after a clinical trial in 600 patients failed to show any improvements in survival or other health measures, such as muscle strength or walking ability.<\/p>\n The company\u2019s voluntary action resolves what could have been a major dilemma for the FDA. The agency\u2019s regulators would not have had a clear path to quickly force the drug from the market if the company had refused to remove it. That\u2019s because the FDA granted the drug full approval, despite the preliminary nature of the company\u2019s data on effectiveness.<\/p>\n The 2022 approval was mainly based on results from one small, mid-stage study that was\u00a0criticized<\/a>\u00a0by some of the agency\u2019s own internal scientists. Normally the agency requires two large, late-stage studies that show a clear benefit before granting approval. But at the time FDA officials explained that \u201cregulatory flexibility\u201d was appropriate when reviewing Relyvrio, \u201cgiven the serious and life-threatening nature of ALS and the substantial unmet need.\u201d<\/p>\n The medication is part of a\u00a0string<\/a>\u00a0of\u00a0drugs<\/a>\u00a0for deadly,\u00a0degenerative<\/a>\u00a0diseases that have won FDA approval in recent years despite questionable evidence they work.<\/p>\n ALS gradually destroys the nerve cells and connections needed to walk, talk, speak and breathe. Most patients die within three to five years of a diagnosis.<\/p>\n Relyvrio is a powder that combines two older drugs: a prescription medication for liver disorders and a dietary supplement associated with traditional Chinese medicine.<\/p>\n Amylyx faced criticism for pricing the drug at $158,000 for a year\u2019s supply. Sales were disappointing, with some patients discontinuing the medicine after only a few months.<\/p>\n<\/div>\n\nSubscribe to Well Adjusted, our newsletter full of simple strategies to work smarter and live better, from the Fortune Well team. Sign up<\/a> for free today.<\/div>\n