AB Science: negative CHMP opinion for masitinib in ALS

(CercleFinance.com) - AB Science announces that the CHMP of the European Medicines Agency has adopted a negative opinion on its application for conditional marketing authorization for masitinib in the treatment of amyotrophic lateral sclerosis (ALS).


The company intends to request a re-examination of the file on the basis of the urgency for patients to gain rapid access to a promising treatment, and the desirability of having the file re-examined by new rapporteurs and a Scientific Advisory Board.

AB Science nevertheless stresses the difficulty of obtaining conditional marketing authorization (MA) in ALS, and cannot guarantee a positive outcome following this re-examination procedure.

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