EMA recommends romosozumab in osteoporosis with fracture risk in postmenopausal women

European Medicines Agency has recommended marketing of romosozumab in severe osteoporosis in postmenopausal women. It has adopted a positive opinion recommending Marketing Authorization for romosozumab for the treatment of severe osteoporosis in postmenopausal women at high risk of fracture and with no history of myocardial infarction or stroke.

Elder population mainly females are liable to suffer a fragility fracture due to osteoporosis and unfortunately, there is a large gap in the management and treatment of osteoporosis, especially in the post-fracture setting.Romosozumab is supposed to fill that gap in treatment of elderly for Osteoporosis and prevention of fractures.

Romosozumab is approved in the U.S. for the treatment of osteoporosis in postmenopausal women at high risk for fracture. It is also approved in Japan and South Korea for the treatment of osteoporosis for women and men at high risk for fracture, in Canada for the treatment of osteoporosis for postmenopausal women at high risk for fracture, and in Australia for the treatment of osteoporosis in postmenopausal women at high risk of fracture and as a treatment to increase bone mass in men with osteoporosis at high risk of fracture.

Romosozumab is a bone-forming monoclonal antibody which is designed to work by inhibiting the activity of sclerostin that simultaneously results in increased bone formation and to a lesser extent decreased bone resorption. It is a novel bone-builder with a dual effect that increases bone formation and to a lesser extent reduces bone resorption.

"After a fracture, postmenopausal women with osteoporosis are five times more likely to fracture in the subsequent year,¹ and these fractures can be life-changing," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "We are pleased by the Committee's opinion because we believe EVENITY is an important therapeutic development for osteoporosis, and we look forward to the European Commission's decision later this year."

The CHMP's recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use throughout the European Union. A European Commission decision is expected by year-end 2019.

"Post-menopausal osteoporosis and fragility fractures are significant women's health issues that are far too often overlooked, with evidence suggesting that an estimated 77 percent of women aged 67 or older remain undiagnosed and untreated in the first 6 months after a fracture.² This is why new treatment options are so important," said Dr. Pascale Richetta, head of bone and executive vice president, UCB. "We believe that the Committee's positive opinion is an important step forward to help improve the lives of postmenopausal women with severe osteoporosis who are at high risk of fragility fractures."

The studies that have been conducted an led to European Medicines Agency recommendation for Romosozumab are as follows-

FRAME (Fracture study in postmenopausal women with osteoporosis) is a randomized, double-blind, placebo-controlled study that evaluated 7,180 postmenopausal women with osteoporosis at risk for fracture. The study evaluated the effectiveness of Romosozumab treatment (210 mg, administered monthly), compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also evaluated the effectiveness of treating with Romosozumab 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 Romosozumab in 4,093 postmenopausal women with osteoporosis and previous fracture history. This event-driven study evaluated 12 months of Romosozumab 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 effectiveness of Romosozumab 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.

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