AB SCIENCE ANNOUNCES THAT HEALTH CANADA HAS STARTED THE REVIEW OF NEW DRUG SUBMISSION FOR MASITINIB IN THE TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS), FOLLOWING ISSUANCE OF A SCREENING ACCEPTANCE LETTER
Paris, 26 May, 2022, 10pm CET
AB Science SA (Euronext - FR0010557264 - AB) today announces that Health Canada has issued a screening acceptance letter for the application of masitinib in the treatment of amyotrophic lateral sclerosis (ALS), meaning that the information and materials submitted by AB Science has been screened and found acceptable for review as a New Drug Submission.
This letter is an important step in the procedure and marks the starting date of the review of the application.
Under the NOC/c policy, Health Canada has a target of 200 calendar days maximum to review the application.
As a reminder, Health Canada had granted in February 2022 authorization to file a new drug submission for masitinib in the treatment of amyotrophic lateral sclerosis (ALS) under the notice of compliance with conditions (NOC/c) policy.
Market authorization under the NOC/c policy allows Health Canada to provide earlier market access to potentially life-saving drugs. NOC/c status is given to eligible drugs that have demonstrated promising clinical effectiveness in clinical trials. The products must be of high quality and possess an acceptable benefit/risk profile. Eligibility is restricted to promising new drug therapies intended for the treatment, prevention or diagnosis of serious, life-threatening or severely debilitating diseases or conditions for which: a) there is no alternative therapy available on the Canadian market or, b) where the new product represents a significant improvement in the benefit/risk profile over existing products.
This authorization was made based on a pre-submission package sent by AB Science including efficacy data of study AB10015, long-term survival data (75 months average follow-up from diagnosis) of study AB10015, and safety data.
The following points were considered by this entity to deliver authorization to file under NOC/c:
Masitinib is represented for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating disease or condition, since ALS is a serious, life-threatening and severely debilitating disease, with a median survival of 2 years after diagnosis.
There is promising evidence of clinical effectiveness that masitinib provides a significant increase in efficacy and/or significant decrease in risk such that the overall benefit/risk profile is improved over existing therapies, preventatives or diagnostic agents for a disease or condition that is not adequately managed by a drug marketed in Canada.
Alain Moussy, co-founder and CEO of AB Science, said “We welcome the decision of Health Canada to accept the masitinib registration dossier in ALS for review. We look forward to working closely with Health Canada on this New Drug Submission and also continue to discuss masitinib with health authorities around the world to determine the most appropriate path to make masitinib available to ALS patients.”
An estimated 3,000 Canadians are currently living with ALS. Each year approximately 1,000 Canadians die from ALS. A similar number of Canadians are diagnosed with ALS each year.
About AB Science
Founded in 2001, AB Science is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKIs), a class of targeted proteins whose action are key in signaling pathways within cells. Our programs target only diseases with high unmet medical needs, often lethal with short term survival or rare or refractory to previous line of treatment.
AB Science has developed a proprietary portfolio of molecules and the Company’s lead compound, masitinib, has already been registered for veterinary medicine and is developed in human medicine in oncology, neurological diseases, inflammatory diseases and viral diseases. The company is headquartered in Paris, France, and listed on Euronext Paris (ticker: AB).
Further information is available on AB Science’s website:
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