AB Science provides an update on the EMA timetable for examination of the masitinib marketing authorization application in ALS
18 Septembre 2023 - 6:05PM
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-a53-1490-assessment-report_en.pdf
[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-a53-1490-questions-answers-marketing-authorisation-holders/applicants-chmp-opinion-article-53-regulation-ec-no-726/2004-referral-nitrosamine-impurities-human-medicinal-products_en.pdf
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).
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applicable regulations, in particular articles 223-1 et seq. of the
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