AB Science submits EMA response for masitinib ALS review, clarifies Health Canada timeline

AB Science has submitted its responses to the European Medicines Agency (EMA) concerning the conditional marketing authorization application for masitinib, a treatment for amyotrophic lateral sclerosis (ALS). These submissions address the questions posed by the EMA at the 120-day mark of the review process.

Concurrently, AB Science has clarified the updated timeline for its interaction with Health Canada regarding the ongoing review of masitinib. The company is awaiting further guidance from Health Canada on the progression of the assessment, with new timelines to be communicated.

Masitinib is a small molecule tyrosine kinase inhibitor being developed by AB Science for various indications, including ALS. The drug's development has reached a stage where it is undergoing regulatory scrutiny by health authorities in Europe and Canada, aiming for market approval.

ALS is a progressive neurodegenerative disease affecting nerve cells and muscle control. Masitinib has been evaluated in clinical trials for its efficacy and safety in ALS patients, and AB Science is pursuing regulatory approval to make the treatment available to patients.