ALS Patients Lose Another Treatment Option

by Denis Storey
April 5, 2024 at 10:59 AM UTC

Amylyx Pharmaceuticals Inc. says it’s pulling Relyvrio from the U.S. and Canadian markets, effective immediately.

Clinical relevance: Amylyx Pharmaceuticals Inc. says it’s pulling Relyvrio from the U.S. and Canadian markets, effective immediately.

  • Results from a Phase III trial involving 664 participants revealed that the drug did not outperform the placebo, leading to the decision.
  • The withdrawal aligns with Amylyx’s commitment to ALS patients and fulfills a promise made to the FDA in 2022.
  • The exit from the market also involves a significant reduction in the company’s workforce.

Amylyx Pharmaceuticals Inc. announced this week that it’s pulling Relyvrio/Albrioza from the U.S. and Canadian markets, effective immediately. European regulators never approved the drug for amyotrophic lateral sclerosis (ALS) treatment.

Last month, the company revealed the results of its nearly year-long data from the Phase III trial. The randomized, double-blind trial included 664 participants. Company officials reported at the time that the drug didn’t perform better than the placebo.

“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 and other neurodegenerative diseases,” Amylyx Co-CEOS Joshua Cohen and Justin Klee said in a press release announcing the move.

The companies had reported earlier that Relyvrio generated more than $380 million in 2023 sales.

The voluntary withdrawal makes good on Amylx’s promise to the U.S. Food and Drug Administration (FDA) when it approved the drug in 2022 that it would pull it off the market if it didn’t meet expectations.

The pharmaceutical company’s exit marks another disappointing milestone for ALS patients and their advocates

“We are saddened by today’s news about Relyvrio and our hearts go out to everyone in the ALS community, which desperately needs new safe, and effective treatments,” the ALS Association remarked in a statement. “We are learning this news with everyone else in real-time so we hope to meet with Amylyx soon and learn more about the trial results.”

Relyvrio’s retreat from the market leaves only a trio of ALS treatments in the U.S. market. And only one of those drugs – Riluzole – has shown evidence of extending patient survival.

Finally, the company added that it’s also eliminating roughly 70 percent of its workforce.

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