FDA Approves Amgen Osteoporosis Drug Prolia

The U.S. Food and Drug Administration approved Amgen’s highly anticipated drug Prolia, an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures. The FDA gave its approval June 1, ahead of its previous target action date of July 25. Analysts have previously estimated Prolia could generate billions of dollars in revenue for Amgen. The safety and efficacy of Prolia in the treatment of postmenopausal osteoporosis was demonstrated in a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the study, Prolia reduced the incidence of vertebral, non-vertebral, and hip fractures in postmenopausal women with osteoporosis. The drug’s most common side effects include back pain, pain in the extremities, musculoskeletal pain, high cholesterol levels, and urinary bladder infections. Serious adverse reactions include hypocalcaemia (low calcium levels in the blood), serious infections, including infections of the skin, and dermatologic reactions such as dermatitis, rashes, and eczema. Prolia was approved with a risk evaluation and mitigation strategy that includes a Medication Guide for patients and communications to health care providers that explains the risks and benefits of the drug. It is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks-based Amgen Inc.