FDA panel backs Amgen's Evenity for osteoporosis

FDA's Bone, Reproductive and Urologic Drugs Advisory Committee voted 18-1 in favor of Evenity romosozumab from Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) to treat osteoporosis in postmenopausal women at high risk of fracture.

Amgen resubmitted a BLA for the mAb against sclerostin in July. During Evenity's initial FDA review in 2017, the partners revealed a previously unseen cardiovascular safety signal in the Phase III ARCH study, prompting FDA to issue a complete response letter. The original BLA was seeking approval to treat osteoporosis in postmenopausal women; Amgen narrowed Evenity's target indication to postmenopausal women at high risk of fracture in the resubmitted BLA (see "Amgen, UCB Again Seeking FDA Nod for Osteoporosis mAb")...