CHMP backs dapagliflozin

EMA's CHMP issued several positive opinions on Friday, including one in favor of Forxiga dapagliflozin from Bristol-Myers Squibb Co. (NYSE:BMY) and partner AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat Type II diabetes. In January, FDA issued a complete response letter for an NDA for the sodium-glucose cotransporter 2 (SGLT2) inhibitor (see BioCentury Extra, Jan. 19).

CHMP also backed approval of Rienso ferumoxytol from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat iron deficiency anemia in chronic kidney disease patients; and Jakavi ruxolitinib from Novartis AG (NYSE:NVS; SIX:NOVN) to treat chronic idiopathic myelofibrosis and myelofibrosis secondary to polycythemia vera or essential thrombocythemia. ...