FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Committee Endorses Amgen’s Postmenopausal Osteoporosis BLA

Jan. 24, 2019

An FDA advisory committee on Wednesday approved the risk-benefit profile of Amgen’s romosozumab, a monoclonal antibody for treatment of osteoporosis.

The Bone, Reproductive, and Urologic Drugs Advisory Committee voted in favor of the risk-benefit profile for treatment of osteoporosis in postmenopausal women at high risk for fracture. The FDA defined high risk as a history of osteoporitic fracture, multiple risks for such fractures, or intolerance to or failure of other osteoporosis therapy.

Sixteen members voted for the proposed indication, while two voted in support of approval but not for the specific indication and one voted against the risk-benefit profile altogether.

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