Failed ALS drug to be pulled from market

WASHINGTON — 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, acknowledging that it didn’t help patients with the deadly neurological condition.

Amylyx Pharmaceuticals said 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.

“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.

The Food and Drug Administration approved the much-debated drug, Relyvrio, in September 2022, following a yearslong advocacy campaign by patients with amyotrophic lateral sclerosis.

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 three ALS medicines available to U.S. patients, only one of which has been shown to extend survival by several months.

Cambridge, Massachusetts-based Amylyx also announced Thursday that it will lay off 70% of its 350-plus employees as part of a major restructuring effort.

Last month, Amylyx said it was considering pulling its drug after a clinical trial of 600 patients failed to show any improvements in survival or other health measures.

The company’s action resolves what could have been a dilemma for the FDA, which would not have had a clear path to quickly force the drug from the market if the company had refused to remove it. That’s because the FDA granted the drug full approval despite the preliminary nature of the company’s data on effectiveness.