CHMP issues second recommendation against AB Science's masitinib

EMA's CHMP for the second time recommended against approval of a resubmitted MAA from AB Science S.A. (Euronext:AB) for Masipro masitinib (Masiviera, Masican, AB1010) to treat systemic mastocytosis in adults. CHMP's concerns echoed those of a May negative opinion for the application, citing GCP failings, changes to the study design while the study was ongoing and limited safety data (see BioCentury, May 19). The committee was also concerned about side effects, including neutropenia and harmful effects on the skin and liver. AB Science said it plans to initiate a confirmatory study in response. ...