Relyvrio ALS Drug Withdrawn by Manufacturer Due to Lack of Efficacy

Amylyx Pharmaceuticals removed a Lou Gehrig's disease, also known as amyotrophic lateral sclerosis (ALS), medication from the market on Thursday, Apr. 11. The move comes after extensive research revealed that the ALS drug Relyvrio did not help neurological patients improve their condition.

AP News reported that the drug maker announced it would stop selling Relyvrio in the US and Canada. Amylyx Pharmaceuticals will no longer prescribe the medicine to new patients. However, Amylyx Pharmaceuticals told current patients they may participate in a free program to continue receiving the drug.

Only three ALS drugs remain available in the US after Relyvrio's removal from the market, with only one extending life by months.

Drug Company to Study Relyvrio Further

Amylyx Pharmaceuticals also restructured, cutting off 70% of its staff. It will also continue investigating Relyvrio and other investigational treatments for rare disorders. Despite the company's shares rising 7.5% on Thursday morning, Amylyx's voluntary action resolves FDA regulatory concerns.

Despite internal scientific opposition, the FDA approved Relyvrio in 2022 based on modest, mid-stage research. This decision highlights the FDA's regulatory flexibility, especially when dealing with severe and life-threatening conditions like ALS.

Because of its dependence on a single clinical trial, FDA officials and other experts questioned Relyvrio's efficacy after its 2022 FDA clearance. Last month, a bigger experiment found that the drug's benefit to patients was no better than chance, causing the company's stock-market worth to plunge 80 percent.

Rarely has Amylyx Pharmaceuticals willingly pulled Relyvrio off the market. During a 2022 FDA conference, participants expressed concerns about the challenge of discontinuing an unsuccessful medicine. Amylyx made the proper choice, according to Johns Hopkins University internist Caleb Alexander, who said such actions are unusual.

The ALS Association praised the action, underscoring the need for scientifically-based market access requirements.

Joshua Cohen and Justin Klee, Amylyx's two CEOs, founded Amylyx. Their surprise at Relyvrio's FDA clearance stemmed from a single experiment that showed ALS patients' deterioration slowed compared to a placebo. Later data analysis showed differences, raising doubt on the drug's effectiveness, according to The Washington Post.

Last year, Amylyx made $380 million on Relyvrio sales. Despite this, the company's market value fell, forcing a shift to alternative therapeutic prospects, notably for Wolfram syndrome, a genetic diabetic illness. Despite the failure, Amylyx pledged to analyze the trial outcomes to guide future ALS research.

Golf May Increase ALS Risk Among Men

Meanwhile, recent research has indicated that participating in recreational activities like golfing, gardening or yard work, woodworking, and hunting may increase your risk of developing ALS, according to a Michigan Medicine study.

The Journal of the Neurological Sciences study examined the hobbies and non-work activities of 400 ALS patients and almost 300 individuals without the disease, per ScienceDaily. Men who played golf had a threefold increased incidence of ALS. Men were also at risk for ALS from gardening, handicrafts, and hunting.

Recreational activities did not increase the risk of female ALS. The report emphasizes the need for more research on ALS risk variables by gender.

More data suggests that environmental exposures, known as the ALS exposome, contribute to ALS development and progression. Potential risk factors include pesticide use in golfing and gardening and formaldehyde exposure in woodworking.