Wednesday, June 2, 2010

Prolia (denosumab) approved by the FDA for the treatment of osteoporosis

The U.S. Food and Drug Administration today approved Prolia (denosumab), an injectable treatment for postmenopausal women with osteoporosis who are at high risk for fractures.  Prolia is a fully-human monoclonal antibody and is the first biologic agent approved for the treatment of osteoporosis. 

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 explains the risks and benefits of the drug.

Prolia is manufactured by Amgen Manufacturing Limited, a subsidiary of Thousand Oaks, Calif.-based Amgen Inc.

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