AB Science: negative opinion from EMA on masitinib.

(CercleFinance.com) - AB Science has announced that the Committee for Medicinal Products for Human Use (CMPHU) of the European Medicines Agency (EMA) has refused the registration of masitinib in the treatment of severe indolent systemic and refractory mastocytosis for symptomatic treatments that are optimally administered in adults.


This decision follows a request to re-assess the case of the previous negative opinion of the CMPHU issued in May 2017. The CHMP considered that there were too many uncertainties that did not permit the analysis of the product's benefit-risk tradeoff.

AB Science plans to launch a confirmatory study in the treatment of severe indolent systemic and refractory mastocytosis for symptomatic treatments that are optimally administered in order to confirm the results of this first pivotal study.


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