Amgen and UCB announced strong support from the U.S. Food and Drug Administration (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 3 studies. Eighteen of 19 members voted yes for approval. In their discussion, the Committee emphasized the need for post-marketing follow-up.
"We are pleased with the Committee's recommendation to approve EVENITY for the treatment of postmenopausal women with osteoporosis at high risk for fracture," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "A fracture due to osteoporosis can be devastating to the lives of patients. After an osteoporotic fracture, a woman is five times more likely to suffer another fracture within the first year, and her risk remains elevated over time if untreated.1 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."
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The EVENITY development program includes 19 clinical studies that enrolled approximately 14,000 patients. Notable Phase 3 studies include FRAME, a placebo-controlled study with 7,180 postmenopausal women with osteoporosis at risk for fracture; ARCH, an active comparator-controlled study with 4,093 postmenopausal women with osteoporosis and with prior history of fracture; and STRUCTURE, 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.
"Evidence suggests that many women who sustain a fragility fracture are not appropriately treated for osteoporosis. This is why new treatment options, like EVENITY, are so important," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "The Committee's recommendation represents a step forward for patients and we look forward to working with our partner, Amgen, in the coming months to bring EVENITY to the patients that need it most."
While the FDA is not bound by the Advisory Committee's recommendations, it takes the advice into consideration when making its decision.
EVENITY was granted marketing authorization – its first approval anywhere in the world – by the Japanese Ministry of Health, Labor and Welfare on Jan. 8, 2019, for the treatment of osteoporosis in patients at high risk of fracture. The European Medicines Agency (EMA) is currently reviewing the marketing application for EVENITY and interactions between our partner and the agency are ongoing.