FDA Requests Additional Data in Romosozumab Biologics License Application

The US Food and Drug Administration (FDA) has published a Complete Response Letter in reply to the Biologics License Application (BLA) submitted by Amgen, Inc. and Union Chimique Belge (UCB) for romosozumab (Evenity™).

Romosozumab, a treatment for postmenopausal women with osteoporosis, is an investigational bone-forming monoclonal antibody designed to inhibit sclerostin.

In an initial filing with the FDA, UCB and Amgen cited data from the phase 3 FRAME study (Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis; ClinicalTrials.gov identifier NCT01575834), which examined data from 7180 women with osteoporosis who received subcutaneous romosozumab injections for 24 months.

The FDA has asked UCB and Amgen to provide additional data on the safety and efficacy of romosozumab, collected in the phase 3 active-comparator ARCH study (A Randomized Phase 3 Study to Evaluate Two Formulations of Romosozumab in Postmenopausal Women With Osteoporosis; ClinicalTrials.gov identifier NCT02016716). The BLA resubmission will also include data from the BRIDGE study (A Double-blind Study to Compare the Safety and Efficacy of Romosozumab [AMG 785] Versus Placebo in Men With Osteoporosis; ClinicalTrials.gov identifier NCT02186171), which evaluated the safety and efficacy of romosozumab in men with osteoporosis.

In total, these phase 3 studies include data from more than 11,000 patients, according to a joint Amgen and UCB press release.

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