Posted on Tuesday, February 22, 2022
AB Science has announced that it has received authorization from the Canadian health authority (Health Canada) to submit a marketing application for masitinib in the treatment of amyotrophic lateral sclerosis (ALS), under NOC/c status ( Notice of Compliance with Conditions).
Marketing authorization under NOC/c status allows Health Canada to provide earlier market access to potentially life-saving drugs. NOC/c status is granted to eligible products that have demonstrated promising clinical efficacy in clinical trials. Products must be of high quality and have an acceptable benefit/risk profile. This status is limited to promising new therapies used for the treatment, prevention or diagnosis of serious, life-threatening or severely disabling diseases for which: a) there is no other therapy available on the Canadian market or, b) the new product provides a significant improvement in the benefit/risk profile compared to existing treatments.
An evaluation entitled Advance Consideration, carried out by an Adjudicating Committee of Health Canada, is necessary before obtaining authorization to submit a dossier under NOC/c status.
This assessment was made on the basis of a pre-submission dossier sent by AB Science including efficacy data from the AB10015 study, long-term survival data (mean follow-up of 75 months since diagnosis) from the AB10015 study, and the safety data.
The committee concluded that AB Science’s application meets the criteria for submission under NOC/c status.
The following points were taken into account to issue the submission authorization under the NOC/c status:
. Masitinib is indicated for the treatment, prevention, or diagnosis of a serious, life-threatening, or severely disabling disease, ALS being a serious, life-threatening, and severely disabling disease, with a median survival of 2 years after diagnosis.
. There is promising evidence of clinical efficacy showing that masitinib provides a significant increase in efficacy and/or a significant decrease in risk, such that the overall benefit/risk profile is improved compared to existing treatments, preventative products or diagnosis in a disease for which there is no satisfactory treatment marketed in Canada.
On this last point, the committee concluded that the data presented provide promising evidence of the clinical efficacy of masitinib at a dose of 4.5 mg/kg/day in the predefined study population, both in terms of slowing disease progression than reduction in mortality in patients with moderate ALS, compared to riluzole administered alone. In addition, despite the absence of a study against the product edaravone, masitinib combined with riluzole showed a survival benefit that was not demonstrated with edaravone. Clinical data also showed an acceptable safety profile in these patients in need of new effective treatments in this progressive and fatal disease. Consequently, masitinib provides an improvement in the overall benefit/risk profile compared to treatments marketed in Canada for ALS.
If granted, an NOC/c status allows the marketing of a drug with conditions. These conditions will be discussed with Health Canada during the procedure.
Under the NOC/c procedure, AB Science has 60 calendar days to file its application and Health Canada has a maximum of 200 calendar days to review the application. AB Science intends to submit its application for marketing authorization in less than 60 days.
It is estimated that 3,000 Canadians are currently living with ALS. Each year, approximately 1,000 Canadians die from ALS. Approximately 1,000 new cases of ALS are diagnosed in Canada each year.
Alain Moussy, co-founder and CEO of AB Science, said: “We welcome Health Canada’s decision to clear the registration dossier for masitinib in ALS. We are committed to working with Health Canada on this submission, which could potentially result in the rapid availability of masitinib for ALS patients first under NOC/c status and then under full registration. We thank all the investigators and researchers who have supported the masitinib development program in ALS for several years. Above all, we are very pleased with this decision for patients and the ALS community, for whom masitinib can offer new therapeutic hope. »
Professor Olivier Hermine, Chairman of AB Science’s Scientific Committee and Member of the Academy of Sciences, said: “As a scientist and director of scientific strategy for AB Science, I am very pleased with this news. The selective targeting of the innate immune system by masitinib, mainly by modulating the activity of mast cells and microglia, has proven to be the right strategy in neurodegenerative diseases and in particular in ALS. In my opinion, it is the unique mechanism of action of masitinib that explains the observed efficacy on the slowing of functional decline after 48 weeks of treatment, measured by the ALSFRS-R score [1]and increased survival by a median of 25 months in patients who initiated treatment before severe functional impairment, ideally at the time of diagnosis, as observed in the very long-term follow-up of 7 years [2]. »
AB Science will hold a virtual conference on Monday, February 28 at 6 p.m., in which will be discussed:
. The filing of the registration application for masitinib in the treatment of ALS in Canada under the NOC/c procedure
. The clinical program for masitinib in all indications
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References
[1] Mora JS, Genge A, Chio A, et al. Amyotroph Lateral Scler Frontotemporal Degener. 2020; 21 (1-2): 5-14.
[2] Mora JS; Bradley WG; Chaverri D, et al. Ther Adv Neurol Disord 2021, Vol. 14: 1–16
Source and visual: AB Science
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