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Biologics application submitted for osteoporosis drug
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A Biologics License Application for romosozumab, an investigational monoclonal antibody much anticipated as a therapy for the treatment of osteoporosis in postmenopausal women at high risk for fracture, has been submitted to the FDA by co-developers Amgen and UCB, according to a press release from Amgen.
Romosozumab inhibits the protein sclerostin to increase bone formation and decrease bone resorption.
The application is based on data from the phase 3 FRActure study in postemenopausal woMen with ostEoporosis (FRAME), an international multicenter, randomized, double-blind, placebo-controlled, parallel-group study in 7,180 postmenopausal women with osteoporosis. Participants were assigned to receive monthly injections of either 210 mg romosozumab or placebo for 12 months, followed by 60 mg denosumab injections every 6 months for 12 months, according to the release.
“Osteoporosis is a chronic disease, largely asymptomatic, and often undetected until a fragility fracture occurs. Many patients often view fragility fractures as part of aging, but these fractures are an indication of a weakened skeleton and a signal for intervention with medication," said Pascale Richetta, MD, head of bone patient value unit and executive vice president, UCB. "We are pleased to submit the first regulatory submission for romosozumab and are committed to seeking global regulatory approvals in the hopes of making this important therapy available for appropriate patients at increased risk of fracture.”