Amgen And UCB Announce FDA Advisory Committee Meeting To Review EVENITY (romosozumab) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture

Amgen (NASDAQ: AMGN) and UCB (Euronext Brussels: UCB) today announced the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) will review data supporting the Biologics License Application (BLA) for EVENITYTM (romosozumab) for the treatment of osteoporosis in postmenopausal women at high risk for fracture at a meeting on Jan. 16, 2019.

"After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year, and these fractures can be life-changing. Yet these patients often remain undiagnosed and untreated and could benefit from a potential new bone forming therapy that has been shown to reduce their risk of fracture within the first year," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We look forward to discussing the efficacy and safety data from our EVENITY clinical program with the members of the Committee."

The EVENITY development program includes three pivotal Phase 3 studies that included more than 11,000 patients: FRAME,1 including 7,180 postmenopausal women with osteoporosis;  ARCH,2 including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE,3 including 245 men with osteoporosis. The BRUDAC will focus its discussion on the FRAME and ARCH studies in its review of the clinical benefit:risk profile of EVENITY, including the cardiovascular safety findings 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.

"We are currently seeing a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated 77 percent of women aged 67 or older remaining undiagnosed and untreated in the first six months after a fracture.4 This is a stark reminder of the need to improve post-fracture care and reduce the risk of future fractures," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We believe EVENITY has the potential to help postmenopausal women with osteoporosis who are at high risk for fracture, and we look forward to the interactions with the members of the Committee."

In July 2018, Amgen and UCB resubmitted the BLA to the FDA for EVENITY. Marketing authorization applications for EVENITY are also ongoing in other parts of the world including Europe and Japan.

About EVENITY™* (romosozumab)
EVENITY is an investigational bone-forming monoclonal antibody and is not approved by any regulatory authority for the treatment of osteoporosis. It is designed to work by inhibiting the activity of sclerostin, which enables EVENITY to rapidly increase bone formation and reduce bone resorption simultaneously. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program. This program included two large fracture trials comparing EVENITY to either placebo or active comparator in more than 10,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.

About the Pivotal EVENITY Clinical Trials
FRAME (Fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis. The study evaluated the effectiveness of EVENITY treatment (210 mg), compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also evaluated the effectiveness of treating with EVENITY for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the risk of new vertebral fractures through 24 months.

ARCH (Active-controlled fracture study in postmenopausal women with osteoporosis at High risk of fracture) is a randomized, double-blind, alendronate-controlled study of EVENITY in 4,093 postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history. The study evaluated 12 months of EVENITY treatment (210 mg)  followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to determine effectiveness in reducing the incidence of clinical fracture (non-vertebral fracture and clinical vertebral fracture) and new vertebral fracture.

BRIDGE (Placebo-controlled study evaluating the efficacy and safety of romosozumab in treating men with osteoporosis) is a randomized, double-blind, placebo-controlled study of 245 men aged 55-90 years with osteoporosis and a history of fragility fracture (excluding hip fracture) or vertebral fracture. The study evaluated the effectiveness of EVENITY treatment for 12 months, compared with placebo, in increasing bone mineral density (BMD) at the lumbar spine and the effect on BMD at the femoral neck and total hip.