Market withdrawal of ALBRIOZA and continued restricted access

Market withdrawal of ALBRIOZA and continued restricted accessHealth Canada is advising of the planned withdrawal of the prescription medicine ALBRIOZA (sodium phenylbutyrate/ursodoxicoltaurine) from the Canadian market by 31 December 2024 and continued restricted access until then in current patients with amyotrophic lateral sclerosis (ALS).ALBRIOZA was authorised in Canada in 2022 under the Notice of Compliance with Conditions (NOC/c) policy for the treatment of adults with ALS, based on results of a phase II study and pending results of trials to verify its clinical benefit.However, in a recent phase III confirmatory study, ALBRIOZA did not meet the primary or secondary endpoints compared with placebo and this led to the decision to withdraw the product from the market.ALBRIOZA is now available only to current patients under Amylyx Pharmaceuticals' Patient Support Program and should not be initiated in new patients.Healthcare professionals are advised to discuss with their patients whether to continue treatment with ALBRIOZA or switch to an alternative drug.Currently, the clinical benefit of ALBRIOZA for the treatment of patients with ALS remains unconfirmed.Health Canada has worked with the manufacturer to update the Canadian product monograph for ALBRIOZA to include this new information and will continue to work with the manufacturer throughout the market withdrawal process.Any serious or unexpected adverse events in patients receiving ALBRIOZA should be reported to Amylyx Pharmaceuticals or Health Canada.Important Safety and Efficacy Information on ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine) -Market Withdrawal and Continued Restricted Access Internet Document : 7 Jun 2024.Available from: URL: https://recalls-rappels.canada.ca/en/alert-recall/important-safety-and-efficacy-information-albrioza-sodium-phenylbutyrateand803858879