AB Science announces an update in the marketing authorization application of masitinib in amyotrophic lateral sclerosis at the European Medicines Agency
27 January 2024 - 4:01AM
UK Regulatory
AB Science announces an update in the marketing authorization
application of masitinib in amyotrophic lateral sclerosis at the
European Medicines Agency
PRESS RELEASE
AB SCIENCE ANNOUNCES AN UPDATE IN THE
MARKETING AUTHORIZATION APPLICATION OF MASITINIB IN AMYOTROPHIC
LATERAL SCLEROSIS AT THE EUROPEAN MEDICINES AGENCY
A DECISION FROM THE EUROPEAN MEDICINES
AGENCY IS EXPECTED DURING THE SECOND QUARTER OF 2024
Paris, 26 January, 2024, 6pm CET
AB Science SA (Euronext –
FR0010557264 – AB) announced that the Committee for Medicinal
Products for Human Use (CHMP) has proposed that AB Science submit a
written response to the List of Outstanding Issues at D195 of the
procedure, instead of addressing these issues through the Oral
Explanation.
At D195 of the procedure, certain major
objections remained, and an Oral Explanation was scheduled on
January 24, 2024 to address these objections.
This week, before the date planned date of the
Oral Explanation, the CHMP has proposed that AB Science addresses
these objections in writing instead of the Oral Explanation.
AB Science has accepted this proposal, which is
unusual at this stage of the procedure, as it offers AB Science the
possibility of giving more detailed responses than what would be
possible during an Oral Explanation, and provides CHMP with more
time to evaluate the responses. A new Oral Explanation is not
mandatory and will be scheduled only if major objections remain
after the review of the written responses.
AB Science now expects an opinion from the CHMP
in the second quarter of 2024.
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).
Forward-looking Statements - AB
Science
This press release contains forward-looking statements. These
statements are not historical facts. These statements include
projections and estimates as well as the assumptions on which they
are based, statements based on projects, objectives, intentions and
expectations regarding financial results, events, operations,
future services, product development and their potential or future
performance.
These forward-looking statements can often be
identified by the words "expect", "anticipate", "believe",
"intend", "estimate" or "plan" as well as other similar terms.
While AB Science believes these forward-looking statements are
reasonable, investors are cautioned that these forward-looking
statements are subject to numerous risks and uncertainties that are
difficult to predict and generally beyond the control of AB Science
and which may imply that results and actual events significantly
differ from those expressed, induced or anticipated in the
forward-looking information and statements. These risks and
uncertainties include the uncertainties related to product
development of the Company which may not be successful or to the
marketing authorizations granted by competent authorities or, more
generally, any factors that may affect marketing capacity of the
products developed by AB Science, as well as those developed or
identified in the public documents published by AB Science. AB
Science disclaims any obligation or undertaking to update the
forward-looking information and statements, subject to the
applicable regulations, in particular articles 223-1 et seq. of the
AMF General Regulations.
For additional information, please contact:
AB Science
Financial Communication & Media Relations
investors@ab-science.com
- CHMP Timetable Update VEng VF
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