EU CHMP does not recommend accelerated assessment of Masican (masitinib) in amyotrophic lateral sclerosis- AB Science

AB Science announced that the EU Committee for Medicinal Products for Human Use (CHMP) did not recommend at this time the accelerated assessment and therefore the review of the conditional marketing authorization application of Masican (masitinib) in amyotrophic lateral sclerosis (ALS) will follow the standard timeline of the European Medicines Agency (EMA). This request for filing was based on clinical data from the phase II/III study AB10015, which was successful on its pre-specified primary endpoint at the interim analysis (192 patients). The study continues blinded in order to generate additional data based on the 394 patients enrolled in the study.

Although the CHMP recognized that the need in ALS, which is a serious and life threatening disease, fits the requirement for accelerated approval, the CHMP considered that, if the application was reviewed under accelerated assessment, it was not certain that AB Science would be able to provide the final data of the phase II/III study AB10015 at the time of the CHMP decision.