FDA Advisory Committee recommends Evenity to treat osteoporosis- Amgen + UCB

Amgen and UCB announced strong support from the FDA Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) for the approval of Evenity (romosozumab) for the treatment of postmenopausal women with osteoporosis at high risk for fracture after reviewing safety and efficacy data from the pivotal Phase III studies. Eighteen of 19 members voted yes for approval.

In their discussion, the Committee emphasized the need for post-marketing follow-up. The Evenity development program includes 19 clinical studies that enrolled approximately 14,000 patients. Notable Phase III studies include FRAME,3 a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk for fracture; ARCH,4 an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture; and STRUCTURE,5 an active comparator-controlled study with 436 postmenopausal women with osteoporosis. The BRUDAC evaluated the FRAME and ARCH studies in its review of the clinical benefit:risk profile of Evenity including the cardiovascular safety finding seen in the ARCH study, for the potential to reduce the risk of fractures and increase bone mineral density (BMD) in postmenopausal women with osteoporosis.