2024-06-20 19:50:00
(PDF model – 158K)
Well being Canada publishes security alerts, public well being advisories, press releases and different notices from the pharmaceutical trade as a service to well being professionals, shoppers and different events. Though Well being Canada approves the remedy product, it doesn’t endorse the product or its producer. Any questions relating to product data must be mentioned together with your well being care skilled.
It is a copy of the letter from Amylyx Prescription drugs, Inc.
Vital Security and Effectiveness Info About Albrioza™ (Sodium Phenylbutyrate and Ursodoxy Taurine) – Market Recall and Ongoing Restrictions on Entry
June 7, 2024
viewers
Healthcare professionals, together with neurologists and different healthcare professionals concerned within the care of sufferers with amyotrophic lateral sclerosis (ALS).
key message
Amylyx Prescription drugs, Inc. will withdraw Albrioza from the Canadian market by December 31, 2024. Licensed for the remedy of lateral sclerosis (ALS) in adults with amyotrophic illness. The confirmatory part 3 research didn’t meet the first or secondary endpoints. Healthcare professionals are suggested to: Do not begin remedy with Albrioza on new sufferers. Albrioza is at present solely out there by means of Amylyx Prescription drugs, Inc.’s Affected person Help Program to sufferers at present receiving Albrioza. Focus on with the affected person whether or not to proceed remedy with Albrioza or swap to a different medicine. The D’Albrioza Canadian Product Monograph (CPM) has been up to date to replicate this new data. Well being Canada will proceed to work with the producer all through the market recall course of.
What’s at stake?
In 2022, Albrioza was licensed beneath NOC-C coverage for the remedy of sufferers with ALS primarily based on outcomes from the Section 2 medical research and pending trial outcomes supporting its medical profit.
Albrioza is at present solely out there to present sufferers by means of the Amylyx Prescription drugs, Inc. Affected person Help Program and shouldn’t be initiated in new sufferers. This was primarily based on a confirmatory Section 3 research that failed to fulfill major or secondary endpoints and led to the choice to withdraw the drug from the market.
Affected medication
Albrioza; Incorporates 3 g sodium phenylbutyrate and 1 g ursine taurine per sachet; out there as powder for oral suspension.
Normal data
Albrioza is indicated for the remedy of grownup sufferers with ALS.
In 2022, Albrioza was accepted beneath NOC-C coverage primarily based on a Section 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group medical research of 137 contributors with familial or sporadic ALS. the results of.
Conditional approval is topic to verification of medical profit in a Section 3, multicenter, randomized research evaluating the efficacy and security of Albrioza to placebo. The confirmatory research was not submitted to Well being Canada for additional overview as a result of it didn’t meet its major efficacy endpoint. No vital variations have been noticed in adjustments in Amyotrophic Lateral Sclerosis Purposeful Score Scale-Revised (ALSFRS-R) complete scores between contributors handled with Albrioza and people handled with placebo in contrast with beginning scores. No statistically vital enhancements in secondary efficacy endpoints have been noticed.
At the moment, the medical advantage of Albrioza within the remedy of ALS sufferers has not been confirmed.
Amylyx Prescription drugs, Inc. will withdraw Albrioza from the Canadian market by December 31, 2024.
Shopper Info
Albrioza is a prescription drug used to deal with individuals with ALS.
Albrioza was accepted primarily based on promising proof of medical effectiveness following a overview by Well being Canada. The producer agreed to conduct additional research to make sure the drug works as supposed.
In a current Section 3 research, ALS contributors obtained Albrioza or a placebo. The research didn’t present that Albrioza was more practical than placebo in slowing the development of ALS.
Sufferers ought to focus on any questions or considerations regarding this data with their well being care skilled. Sufferers ought to proceed to tell their healthcare skilled in the event that they expertise any uncomfortable side effects whereas receiving Albrioza.
Info for healthcare professionals
Amylyx Prescription drugs, Inc. will withdraw Albrioza from the Canadian market by December 31, 2024.
Healthcare professionals ought to be aware the next:
New sufferers mustn’t begin remedy with Albrioza. Albrioza is at present solely out there by means of Amylyx Prescription drugs, Inc.’s Affected person Help Program to sufferers at present receiving Albrioza. For extra details regarding the Affected person Help Program, please contact the Amylyx Prescription drugs, Inc. Affected person Help Program at 1-877-710-0711 or help@amylyxcareteam.ca.
Actions taken by Well being Canada
Well being Canada has labored with the producer to replace the MBM for Albrioza to incorporate this new data. Well being Canada will proceed to work with producers all through the market recall course of
Well being Canada is speaking this necessary message to well being professionals and Canadians within the following methods: Recall and Security Alert Library On the Wholesome Canadians web site. This data will even be disseminated by way of the MedEffect™ electronic mail notification system.
Report a well being or security difficulty
Administration of uncomfortable side effects related to commercially out there well being medicines is dependent upon the well being care professionals and shoppers who report these uncomfortable side effects. Stories of any critical or sudden uncomfortable side effects in sufferers receiving Albrioza must be reported to Amylyx Prescription drugs, Inc. or Well being Canada.
Amylyx Prescription drugs, Inc.,
43 Thorndike Road
Cambridge, Massachusetts, USA
02141
Such. : 1 877-710-0711
To right your mailing tackle or fax quantity, please contact Amylyx Prescription drugs, Inc.
You may report any suspected opposed reactions associated to the usage of dietary supplements to Well being Canada within the following methods:
Name toll-free 1 866-234-2345; or go to the MedEffect Canada web site opposed response report Info on learn how to submit paperwork on-line, by mail or fax.
For every other well being product questions associated to this communication, please contact Well being Canada:
The Items Administration
Electronic mail: pharma_drug_enquiries-renseignements_medicaments_pharma@hc-sc.gc.ca
Telephone: 613-957-0368
Fax: 613-952-7756
Authentic signatory
Marshall Manuel
World Head of Medical Affairs
Amylyx Prescription drugs
1719061228
#Letter #Healthcare #Professionals #Albrioza
