4 April 2024 - Based on top-line results from the Phase 3 PHOENIX trial of AMX0035 in ALS, Amylyx has started a process with the FDA and Health Canada of voluntarily discontinuing the marketing authorisations for Relyvrio/Albrioza.

Amylyx Pharmaceuticals today announced the Company has started a process with the US FDA and Health Canada to voluntarily discontinue the marketing authorizations for Relvvrio/Albrioza (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; also known as AMX0035) and remove the product from the market in the U.S. and Canada based on top-line results from the Phase 3 PHOENIX trial. Relyvrio/Albrioza will no longer be available for new patients as of today. Patients currently on therapy in the US and Canada who, in consultation with their physician, wish to stay on treatment can be transitioned to a free drug program.

Read Amylyx Pharmaceuticals press release