New Indication for Prolia
May 22, 2018 – The U.S. FDA has approved a new indication for Prolia® (denosumab), manufactured by Amgen. It is now indicated to treat glucocorticoid-induced osteoporosis in men and women who have a high risk of fracture.
In a clinical study, the bone mineral density (BMD) of patients on glucocorticoids who were treated with Prolia 60mg every six months was found to improve nearly five times as much compared to patients treated with oral risedronate 5mg daily.
Glucocorticoids include drugs such as cortisone, prednisone, and budesonide. They are used to treat a variety of health conditions, including asthma, multiple sclerosis, Crohn’s disease, and other disorders in which inflammation plays a key role. They may also be prescribed to help prevent rejection following an organ transplant. However, long-term systemic use of these medications can lead to rapid reduction of BMD after just a few months.
Prolia originally received FDA approval in 2010. It is also approved to increase bone mass in several different patient populations, and to treat postmenopausal women who have a high risk for fracture.
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- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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