Osteoporosis drug Romosozumab receives marketing approval in Japan

Monoclonal antibody romosozumab gains first-ever marketing approval in Japan for the treatment of osteoporosis in patients at high risk of fracture announced Amgen and UCB in a joint press release. The drug will be known as Evenity in Japan and would be developed by Amgen Astellas BioPharma K.K.–a joint venture between Amgen and Astellas Pharma Inc., headquartered in Tokyo.

Romosozumab has a dual effect on the bone– it works by binding and inhibiting the activity of the protein sclerostin which increases bone formation and decreases bone breakdown.

Japanese people have the longest life expectancy in the world and with that comes the burden of osteoporotic fractures. In Japan, the osteoporotic fracture is the leading cause of disability that requires long term nursing home care.

"The approval of EVENITY in Japan is a significant milestone that reinforces our commitment to bringing effective treatments to the millions of patients who suffer from osteoporosis," said David M. Reese, M.D., executive vice president of Research and Development at Amgen in a news release.

"A patient with a prior osteoporotic fracture is twice as likely to suffer another fracture if left undiagnosed and without appropriate treatment. With this approval, physicians in Japan now have a new medicine to help patients reduce their risk of fracture."

The approval is based on results of two phase 3 clinical trials– FRAME and BRIDGE. The FRActure study in postmenopausal woMen with ostEoporosis (FRAME), included 7,180 postmenopausal women with osteoporosis. The women received romosozumab 210 mg s.c. or placebo once monthly for 12 months, followed by denosumab 60 mg s.c. once every 6 months in both groups for 12 months. The drug significantly increased spine and hip BMD and reduced vertebral and clinical fracture risk.

The BRIDGE study (placeBo-contRolled study evaluating the efficacy anD safety of romosozumab in treatinG mEn with osteoporosis) involved 245 men with osteoporosis (163 romosozumab, 82 placebo) randomized 2:1 to receive either 210 mg romosozumab or placebo subcutaneously once monthly for 12 months. Men on Romosozumab showed a significant bone mineral density (BMD) gains at the lumbar spine, total hip and femoral neck compared to placebo at six and 12 months.

The approval is also significant because FDA rejected Amgen’s initial marketing application for Romosozumab in the US because of cardiovascular side effects of the drug in ARCH trial. The drug is also under regulatory review in Europe.

The Japanese Pharmaceuticals and Medical Devices Agency undertook a thorough review of the safety profile of EVENITY, including the cardiovascular safety findings in the ARCH trial.

Toshio Matsumoto, M.D., Ph.D., emeritus professor of Tokushima University and the advisor of the university's Fujii Memorial Institute of Medical Sciences said in the press release, "Physicians have been waiting for a new therapeutic option. I have great hope that the approval of EVENITY will help reduce the fracture risk for patients in Japan."

"Patients with a prior fracture face the risk of having another fracture and particularly stand to benefit from the option of a new bone-forming agent," he further added.

Meanwhile, During the second review cycle, the US Food and Drug Administration (FDA) Bone, Reproductive, and Urologic Drugs Advisory Committee (BRUDAC) recently voted in favor of approving Amgen and UCB’s romosozumab (EVENITY) In the US for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The committee indicated that the drug benefits for treatment of postmenopausal osteoporosis outweigh its risk.

Press release