FDA Approves Amgen’s Prolia Drug For Osteoporosis in Postmenopausal Women

The Food and Drug Administration June 1 announced that it has approved Prolia (denosumab), an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Prolia works to decrease the destruction of bone and to increase bone mass and strength, FDA said. A 60 mg injection of Prolia is recommended once every six months. Prolia was approved with a risk evaluation and mitigation strategy (REMS) that includes a medication guide for patients and communications to health care providers that explain the risks and benefits of the drug, the agency said.

Amgen Inc., the manufacturer of the ...