press release
AB Sciences Announces Update on European Medicines Agency Marketing Authorization Application for Masinib in Amyotrophic Lateral Sclerosis
Decision from the European Medicines Agency is expected to be decided during the second quarter of 2024
Paris, January 26, 2024, 6:00 PM CET
AB Science SA (Euronext – FR0010557264 – AB) The Committee for Medicinal Products for Human Use (CHMP) has issued a written response to the list of outstanding issues in D195 of the procedure, rather than addressing these issues through an oral briefing. announced that they have proposed to AB Science to submit the following. .
Several major objections remained in proceeding D195, and oral briefing was scheduled for January 24, 2024, to address these objections.
This week, ahead of the scheduled date for the oral briefing, CHMP proposed that AB Science address these objections in writing in lieu of an oral briefing.
AB Science has accepted this proposal, which offers AB Science the possibility of providing a more detailed response than would be possible with an oral explanation and gives CHMP more time to evaluate the response. given, which is unusual at this stage of the procedure. A new oral briefing is not required and will only be scheduled if significant objections remain after consideration of the written response.
AB Science currently expects an opinion from CHMP in the second quarter of 2024.
About AB Science
AB Science, founded in 2001, is a pharmaceutical company specializing in the research, development and commercialization of protein kinase inhibitors (PKI). PKI is a type of target protein whose actions are key to intracellular signal transduction pathways. Our programs target only diseases with high unmet medical need, often fatal with short survival, rare, or refractory to previous treatments. .
AB Science has developed a unique portfolio of molecules, and its lead compound, masitinib, is already registered for veterinary medicine and is being developed in human medicine in oncology, neurological diseases, inflammatory diseases, and viral diseases. It has been. The company is headquartered in Paris, France and listed on Euronext Paris (ticker: AB).
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