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# FDA Accepts BLA for Romosozumab in Osteoporosis
- URL: https://www.fdaweb.com/fda-accepts-bla-for-romosozumab-in-osteoporosis/
- Published: 2016-09-28T12:00:00.000Z
- Updated: 2026-09-14T21:35:27.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136935

FDA has accepted for review an Amgen and UCB BLA for romosozumab, an investigational monoclonal antibody for treating osteoporosis in postmenopausal women at increased risk of fracture. The companies say romosozumab works by binding and inhibiting the activity of the protein sclerostin, a protein naturally occurring in the bone, thereby increasing bone formation and decreasing bone resorption. The agency has set a user fee review target action date of 7/19/2017.

The submission is based on data from a Phase 3 study called FRAME that involved 7,200 patients. The study evaluated the therapy’s effectiveness compared with placebo in reducing the risk of new vertebral fractures through 12 months. FRAME 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.