Drug manufacturer Amylyx Pharmaceuticals has announced plans to remove Relyvrio, a drug used to treat ALS, from the market after lackluster results from a phase III trial. This decision will leave only two other ALS drugs on the market, Riluzole and edaravone. Relyvrio, also known as Albrioza in Canada, is used to treat the fatal and progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord.
The process to remove Relyvrio from the market in both Canada and the U.S. will begin immediately, and it will no longer be available to new patients. However, current patients who wish to continue taking the drug can do so free of charge. The announcement follows the results of a 48-week phase III trial involving 664 participants, where the drug was found to be no more effective than a placebo, though it was deemed safe since no new side effects occurred.
Watchdog group Public Citizen had previously urged the drug manufacturer to remove Relyvrio from the market, stating that the results of the phase II trial were inconclusive. Despite this, the FDA granted accelerated approval for the drug in September 2022. The advisory committee had initially expressed doubts about the drug’s effectiveness but later changed its stance, citing the life-threatening nature of ALS as a reason for the approval.
Amylyx Pharmaceuticals, in a statement, mentioned that the decision to remove Relyvrio from the market was informed by the PHOENIX trial results, engagement with regulatory authorities, and discussions with the ALS community. The company will continue to focus on advancing AMX0035 for the treatment of Wolfram syndrome, with the results of its phase II trial set to be announced on April 10 during a company webcast. The company will also reduce its workforce by 70% to focus on upcoming clinical milestones.
Relyvrio generated $381 million in sales in 2023, according to Amylyx Pharmaceuticals’ financial report, with $49 million in profits. Currently, Riluzole and edaravone are the only other FDA-approved drugs for ALS. Riluzole works by blocking the release of glutamate in the nervous system, while edaravone slows down nerve damage caused by worsening ALS symptoms. It is important to note that these medications have limited efficacy in terms of extending life expectancy and slowing down the progression of the disease.
