FDA Panel Recommends New Osteoporosis Option

In an 18 to 1 vote, an advisory panel to the FDA has recommended the approval of romosozumab (Evenity) for use in postmenopausal women with osteoporosis and high fracture risk.

The drug was first approved by the Japanese Ministry of Health, Labor, and Welfare in January of 2019.

The development program for Evenity includes 19 clinical studies involving approximately 14,000 patients. Notable studies include FRAME, a placebo-controlled study of 7189 postmenopausal women with osteoporosis, ARCH, an active comparator-controlled study with 4093 postmenopausal women with osteoporosis and prior history of fracture, and STRUCTURE, an active comparator-controlled study with 436 postmenopausal women with osteoporosis.

“Despite available therapies, these women who are at high risk for fracture could benefit from an additional treatment option that has the potential to both build new bone and slow existing bone loss. We are committed to working with the FDA to help make EVENITY available to appropriate patients," said David M Reese, MD, executive vice president of Research and Development and Amgen.

—Michael Potts

Reference:

Amgen. Amgen and UCB receive positive vote from FDA advisory committee in favor of approval for EVENITY™ (romosozumab) [press release]. https://www.prnewswire.com/news-releases/amgen-and-ucb-receive-positive-vote-from-fda-advisory-committee-in-favor-of-approval-for-evenity-romosozumab-300779812.html.