Other safety alerts
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| Canada: Important Safety and Efficacy Information on ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine) – Market Withdrawal and Continued Restricted Access |
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Health Canada announces that Amylyx Pharmaceuticals, Inc. will withdraw ALBRIOZA from the Canadian market by December 31, 2024. In 2022, ALBRIOZA (sodium phenylbutyrate and ursodoxicoltaurine) was authorized under the Notice of Compliance with Conditions (NOC/c) policy for the treatment of adult patients with amyotrophic lateral sclerosis (ALS). The Phase 3 confirmatory study did not meet its primary or secondary endpoints.
Healthcare professionals are advised of the following:
- ALBRIOZA should not be initiated in new patients.
- ALBRIOZA is now only available under Amylyx Pharmaceuticals, Inc.’s Patient Support Program for patients who wish to continue receiving ALBRIOZA.
Health Canada has worked with the manufacturer to update the he Canadian Product Monograph for ALBRIOZA to include this new information. Health Canada will continue to work with the manufacturer throughout the market withdrawal process.
Please refer to the following website in Health Canada for details:
http://recalls-rappels.canada.ca/en/alert-recall/important-safety-and-efficacy-information-albrioza-sodium-phenylbutyrate-and
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Saturday, June 8, 2024
Issued at HKT 12.00
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