AB Science provides an update on the EMA timetable for examination of the masitinib marketing authorization application in ALS

PRESS RELEASE

AB SCIENCE PROVIDES AN UPDATE ON THE EUROPEAN MEDICINES AGENCY'S TIMETABLE FOR EXAMINATION OF THE MARKETING AUTHORIZATION APPLICATION OF MASITINIB IN AMYOTROPHIC LATERAL SCLEROSIS

BASED ON THE UPDATED TIMETABLE, A DECISION FROM THE EUROPEAN MEDICINES AGENCY IS EXPECTED DURING THE FIRST QUARTER OF 2024

Paris, 18 September, 2023, 6pm CET

AB Science SA (Euronext – FR0010557264 – AB) today provided an update on the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) timetable for examination of the masitinib marketing authorization application in amyotrophic lateral sclerosis (ALS).

The timetable extension was requested by AB Science in order to address a question from the CHMP that arose following implementation of a guidance [1], updated on July 28, 2023 [2], from the EMA. This guidance requested all marketing authorisation holders to review their manufacturing processes for all products containing chemically synthesised or biological active substances to identify and, if necessary, mitigate the risk of presence of nitrosamine impurities.

Because performing this activity was not compatible with the conventional 30 days stop-clock, AB Science requested an extension of this stop-clock in order to complete a risk evaluation of the manufacturing process in terms of risk of formation of nitrosamines in active substance and finished product.

An extension of clock-stop is not automatic. A request for extension together with a corresponding scientific justification must be submitted by the applicant and needs to be discussed in a CHMP plenary session. AB Science’s request was accepted during the September 11-14, 2023 CHMP session.

Based on this updated timetable, the CHMP decision on masitinib marketing authorization in ALS is expected during the first quarter of 2024.

Based on the current stage of investigations, AB Science is confident that the current manufacturing process of masitinib complies with this new EMA guidance.

References

[1] EMA/369136/2020: Nitrosamines EMEA-H-A5(3)-1490 - Assessment report. https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a5 ...   

[2] EMA/409815/2020 Rev.17: Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. https://www.ema.europa.eu/en/documents/referral/nitrosamines-emea-h-a5 ...