Amylyx Pharmaceuticals, the maker of the newest approved treatment for amyotrophic lateral sclerosis, has announced its decision to withdraw the drug from the market. This move comes after a large clinical trial failed to provide evidence of the treatment’s effectiveness.
The drug, known as Relyvrio in the United States and Albrioza in Canada, will no longer be available for new patients. However, existing patients who wish to continue the medication can transition to a free drug program offered by the company.
Despite being one of the few treatments available for A.L.S., the medication did not demonstrate significant benefits in the clinical trial. The FDA had initially approved the drug in September 2022, citing safety data and the urgent need for effective treatments for A.L.S. patients.
Following the trial results, Amylyx Pharmaceuticals has also announced a workforce reduction of 70%. The company will continue to study the drug for other rare diseases, such as Wolfram syndrome and progressive supranuclear palsy.
A recent class-action lawsuit has been filed against Amylyx by investors, alleging that the company misrepresented the commercial potential of Relyvrio and failed to disclose critical information about the treatment’s efficacy. The lawsuit also claims that the company attempted to conceal negative data from investors.
The development of Relyvrio was initiated by Justin Klee and Joshua Cohen, who envisioned a combination of taurursodiol and sodium phenylbutyrate to protect neurons in diseases like A.L.S. The FDA’s approval process for the drug involved a single Phase 2 trial and additional confirmatory data, despite initial recommendations for further testing.
The decision to withdraw the drug follows the disappointing results of a 48-week trial involving 664 patients. Despite the setback, Amylyx remains committed to finding effective treatments for neurodegenerative diseases.
