FDA Approved Amgen's Injectable Osteoporosis Drug

Filed in archive Drugs, Vaccines and Therapeutics on June 1, 2010

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Amgen's injectable osteoporosis drug - Prolia® - has just been approved by the US FDA as treatment for postmenopausal women with osteoporosis who are at high risk for fractures.

Osteoporosis is characterized by weak bones that are more likely to break. Women are more prone to osteoporosis especially those at postmenopausal stage. Prolia®'s safety and efficacy has been demonstrated by a three-year, randomized, double-blind, placebo-controlled trial of 7,808 postmenopausal women ages 60 to 91 years. In the said study, Prolia® reduced the incidence of vertebral, non-vertebral and hip fractures in postmenopausal women with osteoporosis.

Prolia® has already received EU marketing authorization even before the FDA approval. The product has been approved in all 27 European Union member states plus Norway, Iceland and Liechtenstein. This European approval of Prolia® marks the first approval of the product worldwide.