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).
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