FDA Committee Votes 18-1 for Amgen's Osteoporosis Drug

The U.S. Food and Drug Administration (FDA)’s Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) voted 18 to 1 to recommend Amgen and UCB’s Evenity (romosozumab) to treat postmenopausal women with osteoporosis. This follows a 2017 rejection by the agency, requesting more data. As Jefferies analyst Michael Yee wrote in a note to clients, Amgen is “back in the game.” Evenity is a bone-forming monoclonal antibody. It inhibits the activity of sclerostin, which allows it to rapidly increase bone formation and simultaneously reduce bone resorption. The companies’ programs for Evenity development included 19 clinical studies involving about 14,000 people.
The Phase III trials included FRAME, a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk of fracture; ARCH, an active comparator-controlled trial with 4,090 postmenopausal women with the same fracture risk; and STRUCTURE, which studied 436 postmenopausal women with osteoporosis. The BRUDAC Adcom evaluated FRAME and ARCH in terms of the clinical benefit-risk profile of the drug, including cardiovascular safety issues seen in the ARCH study. In the U.S. fifty percent of women over the age of 50 will experience an osteoporotic fracture.