FDA approves Amgen’s osteoporosis drug Prolia


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In a long-awaited development, the first drug in a new class of osteoporosis medications was approved Tuesday by the Food and Drug Administration. The drug is Amgen’s injectable treatment, Prolia. The medication, for postmenopausal women with osteoporosis, is expected to be popular as concerns have mounted about the safety of the class of osteoporosis drugs called bisphosphonates. Bisphosphonates, including the medication Fosamax, have been linked to cases of jaw necrosis.

Prolia works differently than other medications for bone health. It blocks production of cells called osteoclasts that break down bone. Prolia will require an injection every six months. The drug was shown in clinical trials to reduce vertebral, non-vertebral and hip fractures. Side effects include back pain, musculoskeletal pain, high cholesterol levels and bladder infections as well as some skin infections and low calcium levels in the blood. Prolia too may contribute to jaw necrosis, according to the FDA. As part of the approval agreement, Amgen will continue to gather data to monitor the safety of Prolia.


The drug’s wholesale cost will be $825 per injection.

-- Shari Roan