Amgen, UCB Receives Negative Opinion on EMA Application EVENITY™ in EU

Amgen and UCB announced the companies have been informed the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application for EVENITYTM (romosozumab) for the treatment of severe osteoporosis. The companies intend to submit a written notice for a re-examination by the CHMP.

"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 new treatment option with 12 monthly doses to reduce their risk of a fracture," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are disappointed by the Committee's opinion and continue to believe that EVENITY has a positive benefit:risk profile. Amgen and UCB remain committed to working with regulatory authorities around the world to bring EVENITY to patients and physicians who need additional treatment options for osteoporosis."

The opinion is based on results from a large development program including three pivotal Phase 3 studies comprised of nearly 12,000 patients: FRAME, including 7,180 postmenopausal women with osteoporosis at risk for fracture; ARCH, including 4,093 postmenopausal women with osteoporosis at high risk for fracture; and BRIDGE, including 245 men with osteoporosis.

"We are disappointed with the CHMP opinion and believe that the body of evidence submitted supports a positive benefit:risk profile for EVENITY and its use in helping address the urgent need to improve post-fracture care and reduce the risk of painful, disabling fractures in postmenopausal women with severe osteoporosis at high risk of fracture," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "Together with Amgen we will seek a re-examination of the CHMP opinion. The re-examination process gives us the opportunity to clarify our position on the submitted data with the goal of making EVENITY available to postmenopausal women at high risk of fracture in the EU."

EVENITY (romosozumab-aqqg) was approved by the U.S. Food and Drug Administration (FDA) in April 2019, for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY is also approved in Japan and South Korea for the treatment of osteoporosis for women and men at high risk for fracture and in Canada for the treatment of osteoporosis for postmenopausal women at high risk for fracture.

EVENITY is a bone-forming monoclonal antibody. It is designed to work by inhibiting the activity of sclerostin, which simultaneously results in increased bone formation and to a lesser extent decreased bone resorption. The EVENITY development program includes 19 clinical studies that enrolled approximately 14,000 patients. EVENITY has been studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program that included two large fracture trials comparing EVENITY to either placebo or active comparator in nearly 11,000 postmenopausal women with osteoporosis. Amgen and UCB are co-developing EVENITY.

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 efficacy of EVENITY treatment (210 mg, administered monthly), compared with placebo, in reducing the incidence of new vertebral fractures through 12 months. The study also evaluated the efficacy of treating with EVENITY for 12 months followed by denosumab for 12 months, compared with placebo followed by denosumab, in reducing the incidence 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 and previous fracture history. This event-driven study evaluated 12 months of EVENITY treatment (210 mg, administered monthly), followed by at least 12 months of alendronate treatment (70 mg), compared with alendronate treatment alone, to assess its efficacy in reducing the risk of clinical fracture (non-vertebral fracture and symptomatic vertebral fracture) through the primary analysis period and the incidence of new vertebral fracture at 24 months.

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 efficacy of EVENITY treatment (210 mg, administered monthly) 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.

Worldwide, one in three women and one in five men, over the age of 50, will suffer a fragility fracture due to osteoporosis and with an aging population these numbers will rise. Yet despite this, there is a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting, with an estimated four out of five patients remaining undiagnosed and untreated after a fracture. Without proper care or access to effective intervention options, they remain at risk of painful and disabling fractures in the future.

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