FDA to Review Investigational Bone-Forming Monoclonal Antibody for Osteoporosis
Amgen and UCB announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.
The BLA submission was supported by data from the pivotal FRAME (FRActure study in postemenopausal woMEn with osteoporosis) study, an international, multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 trial in 7,180 postmenopausal women with osteoporosis. The study evaluated the safety and effectiveness of romosozumab 210mg SC once a month vs. placebo in reducing the risk of new vertebral fractures through 12 months. The companies intend to present detailed study findings at an upcoming medical congress.
Romosozumab is an investigational bone-forming monoclonal antibody designed to inhibit the protein sclerostin and to increase bone formation and decrease bone breakdown.