Posted from: Monday, June 04, 2018 - 11:20 AM - Present

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.

Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval.  Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval.  Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.

*This is provided for information only.  The reference to any medication above does not mean the medication is covered by your plan.

Last Updated Saturday, December 15, 2018 - 12:01 AM.