ALS drug will be pulled from US market after study showed patients didn't benefit
abcnews.go.comThe maker of a drug for Lou Gehrig’s disease that recently failed in a study says it will pull the medicine from the U.S. 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 it didn't help patients with the deadly neurological condition.
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.
“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 years-long advocacy campaign by patients with amyotrophic lateral sclerosis, or 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 U.S. patients, only one of which has been shown to extend survival by several months.
Cambridge, Massachusetts-based Amylyx also said Thursday it will lay off 70% of its more than 350 employees as part of a major restructuring effort. Company executives said they plan to continue studying Relyvrio and another experimental drug for several rare diseases, including
Read more on abcnews.go.com
