CHMP issues negative opinion for AB Science's masitinib after French trials halted

EMA's CHMP adopted a negative opinion of an MAA from AB Science S.A. (Euronext:AB) for masitinib (AB1010) to treat patients with smoldering or indolent systemic severe mastocytosis unresponsive to optimal symptomatic treatments. The opinion follows a request from the French National Agency for Medicines and Health Products Safety (ANSM) to halt ongoing clinical trials of masitinib in France. AB Science plans to request a re-examination.

ANSM's decision to suspend the French trials followed an EMA inspection that found deviations from Good Clinical Practice in the Phase III AB06006 study of masitinib to treat mastocytosis. The company noted that CHMP's negative opinion was based primarily on these deviations. ...