The maker of a drug for Lou Gehrig’s disease, Amylyx Pharmaceuticals, has announced the voluntary withdrawal of the medicine from the market following its failure in a large study. The drug, Relyvrio, did not demonstrate efficacy in helping patients with the deadly neurological condition, prompting the company to cease sales and marketing in the U.S. and Canada.
Despite receiving FDA approval in September 2022, Relyvrio's lack of effectiveness has led to its removal from the market, leaving only three ALS medicines available to U.S. patients. This decision has been met with disappointment by patients and advocates who have been advocating for more treatment options for ALS.
In response to the drug's failure, Amylyx Pharmaceuticals will be laying off 70% of its workforce as part of a major restructuring effort. The company plans to continue research on Relyvrio and another experimental drug for rare diseases such as Wolfram syndrome.
The FDA's approval of Relyvrio was based on a single mid-stage study, which raised concerns among some of the agency's internal scientists. The drug's high price of $158,000 for a year's supply also contributed to its underwhelming sales performance.
ALS, a degenerative disease that affects nerve cells and bodily functions, has limited treatment options, with most patients succumbing to the disease within three to five years of diagnosis. The withdrawal of Relyvrio underscores the challenges in developing effective therapies for such devastating conditions.
