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, ClinicalTrials.gov identifier NCT01575834) 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 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. The companies intend to present detailed study findings at an upcoming medical congress.
Arthralgia and nasopharyngitis were the most commonly reported side effects noted.
Romosozumab is an investigational bone-forming monoclonal antibody designed to inhibit the protein sclerostin and to increase bone formation and decrease bone breakdown.
The NCT01575834 clinical trial was funded by Amgen, the manufacturer of romosozumab.
Amgen Press Release. Amgen And UCB Submit Biologics License Application For Romosozumab To The FDA. published online July 21, 2016. Accessed July 24, 2016.
This article originally appeared on MPR