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news.AB Science announced that the 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 masitinib in amyotrophic lateral sclerosis (ALS) will follow the standard timeline of the European Medicines Agency (EMA).
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This request for filing was based on clinical data from the phase 2/3 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 2/3 study AB10015 at the time of the CHMP decision.
As a reminder, the interim analysis results of study AB10015 were known in April 2016. The filing of the application for conditional marketing authorization is planned toward the end of Q3 2016, and the final results of study AB10015 should be available to AB Science by the end of Q1 2017.
Under accelerated assessment procedure, the CHMP should adopt a decision between 90 days at minimum and 180 days at maximum, including one month of clock-stop that the sponsor must respect to respond to the agency questions. Therefore, with a filing in September 2016, the CHMP vote would have likely occurred at the latest in March 2017.
By contrast, the assessment period under standard procedure is 210 days plus the time of clock-stops where sponsor has to respond to the agency questions. Therefore, under standard timeline, the CHMP vote will likely occur in Q3 2017 after the final data of the phase 2/3 study AB10015 are available.
The CHMP also indicated that a review under accelerated assessment may be reconsidered once the final data are available.
About masitinib
Masitinib is a new orally administered tyrosine kinase inhibitor that targets mast cells and macrophages, important cells for immunity, through inhibiting a limited number of kinases. Based on its unique mechanism of action, masitinib can be developed in a large number of conditions in oncology, in inflammatory diseases, and in certain diseases of the central nervous system. In oncology due to its immunotherapy effect, masitinib can have an effect on survival, alone or in combination with chemotherapy.
Through its activity on mast cells and microglia and consequently the inhibition of the activation of the inflammatory process, masitinib can have an effect on the symptoms associated with some inflammatory and central nervous system diseases and the degeneration of these diseases.