Health Canada issues a Notice of Non-Compliance–Withdrawal for masitinib

March 1, 2024 – AB Science announced that Health Canada has issued a Notice of Non-Compliance–Withdrawal (NON-W) for masitinib in ALS due to unresolved clinical concerns and data reliability issues.  

A Notice of Non-Compliance-Withdrawal (NON-W) indicates that the drug submission did not meet the necessary standards and requirements set by Health Canada, resulting in the review process being incomplete and non-compliant at the time of issuance. 

AB Science has the opportunity to submit a request for reconsideration within 30 days, during which Health Canada would re-examine the decision based on additional data provided with the goal to ensure that masitinib meets the necessary regulatory standards for ALS treatments in Canada. 

We will continue to post updates as we become aware of them. You can read more in AB Science’s press release. Specific questions about the treatment can be directed to the ALS Canada Research Team at research@als.ca.