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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