CHMP knocks Evenity for osteoporosis, backs Giapreza for hypotension

EMA's CHMP issued a basket of opinions Friday, including a negative opinion for Amgen's osteoporosis drug Evenity, and a recommendation for La Jolla's hypotension therapy Giapreza.

The agency recommended against approval of Evenity romosozumab-aqqg from Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) to treat severe osteoporosis in postmenopausal women, citing increased risk of cardiovascular adverse events as well as higher mortality in patients over age 75 who received the drug in trials. The partners plan to request reexamination of the MAA for the mAb against sclerostin, which FDA approved in April to treat osteoporosis in postmenopausal women at high risk of fracture. ...