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Manufacturer Withdraws Amyotrophic Lateral Sclerosis Drug AMX0035 (Relyvrio) From Market

“The FDA should never approve a drug without clear evidence of efficacy,” says Public Citizen

WASHINGTON, D.C. – Amylyx Pharmaceuticals said on Thursday that it would withdraw AMX0035 (sodium phenylbutyrate and taurursodiol, sold as Relyvrio) from the market. A large clinical trial recently found that the drug did not provide any benefit to patients with amyotrophic lateral sclerosis (ALS). In 2022, Public Citizen urged the Food and Drug Administration (FDA) not to approve AMX0035 because the data from a single small clinical trial and its open-label extension study were inconclusive. According to STAT, Amylyx charged $163,000 a year for AMX0035, leading to $381 million in sales and $49 million in profits in 2023. In March 2024, when the results of the large clinical trial were announced, Public Citizen called for the prompt removal of the drug from the market. Dr. Robert Steinbrook, director of Public Citizen’s Health Research Group, released the following statement.

“As the FDA should have never approved AMX0035, the company’s announcement that the drug will be withdrawn from the market is welcome news. Although amyotrophic lateral sclerosis is a devastating disease and effective treatments are urgently needed, the FDA’s approval of AMX0035 allowed the company to make tens of millions of dollars of profits from selling a worthless drug for which there was never evidence of efficacy. Patients were duped, individuals and payors needlessly spent hundreds of millions of dollars, and a company was unjustly enriched. All of these consequences were preventable, and the FDA must take steps to ensure they never happen again. The FDA should never approve a drug without clear evidence of efficacy.”