CHMP backs Iclusig, Stribild, Xarelto label expansion
Among a number of positive opinions issued on Friday, EMA's CHMP recommended approval of an MAA for Iclusig ponatinib from Ariad Pharmaceuticals Inc. (NASDAQ:ARIA) to treat chronic myelogenous leukemia (CML) and Philadelphia-chromosome positive (Ph+) acute lymphoblastic leukemia (ALL). The product is under accelerated assessment, with a decision from the European Commission expected mid-year. FDA granted accelerated approval to the pan- BCR-ABL tyrosine kinase inhibitor (TKI) for the indications in December. Ariad was off $0.33 to $19.38 on Friday.
CHMP also backed approval of Stribild (formerly Quad) from Gilead Sciences Inc. (NASDAQ:GILD) to treat HIV-1 infection in treatment-naïve adults. FDA approved the once-daily tablet comprising elvitegravir, cobicistat and Gilead's HIV drug Truvada emtricitabine/tenofovir for the indication in August. Gilead was up $0.97 to $45.51 on Friday. ...