Biologics License Application Submitted for Osteoporosis Treatment

The drug binds to sclerostin and increases bone formation for osteoporosis in postmenopausal women.

Amgen and UBC recently submitted a Biologics License Application (BLA) to the FDA for romosozumab, which treats osteoporosis in postmenopausal women.

This drug is an investigational monoclonal antibody that binds to and inhibits the protein sclerostin, according to Amgen. This can increase bone formation and stop bone resorption.

“Osteoporosis is a large public health problem, yet is often overlooked, even in patients who have already experienced an osteoporotic fracture,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “This BLA submission is an exciting milestone; romosozumab has the potential to reduce the risk of fractures and help patients suffering from this serious disease.”

The BLA was based on the phase 3 FRAME study, which included 7180 patients with postmenopausal osteoporosis to examine vertebral fractures. Patients either received romosozumab or placebo for 12 months.

Researchers also analyzed whether 12 months of romosozumab followed by 12 months of denosumab was more effective than placebo followed by denosumab, both taken for 12 months.

Clinical fracture risk reduction, non-vertebral fracture risk reduction and other endpoints were analyzed, according to Amgen.

The most common adverse effects were arthralgia and nasopharyngitis.

“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 and executive vice president at 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.”