Amgen and UCB File BLA for Romosozumab

Amgen and UCB have filed a Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture, Amgen said in a July 21, 2016 press announcement. According to the company, romosozumab works by binding and inhibiting sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption.

The BLA includes results from the Phase III FRAME study, which studied the drug’s effectiveness in treating osteoporosis in approximately 7200 patients. FRAME evaluated the effectiveness of romosozumab treatment, compared with placebo, in reducing the risk of new vertebral fractures through 12 months. The study also further evaluated if romosozumab treatment for 12 months followed by denosumab treatment for 12 months, compared with placebo followed by denosumab treatment, was effective in reducing the risk of new vertebral fractures through 24 months.