Data from Pharmawand - Curated by Toby Galbraith - Date added 11 October 2017

Amgen announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP). The sBLA, which was submitted on 28 July 2017 , is based on a Phase III study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of May 28, 2018 .

Glucocorticoid medications, which are used to treat many inflammatory conditions, can cause significant side effects, including bone loss. GIOP is the most common form of secondary osteoporosis, and it is estimated that one percent of the U.S. population is treated long-term with glucocorticoid medications. Within the first three months of beginning glucocorticoid treatment, fracture risk increases by up to 75 percent, with bone mineral density (BMD) continuing to decline significantly in the months that follow.

Comments

You will need to login, to leave a comment.

epgonline.org is not monitored for collection of adverse event reports. Any adverse events should be reported to your national reporting agency and/or the manufacturer.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Cushing's Syndrome

Cushing’s syndrome shares symptoms such as hypertension, glucose intolerance and obesity with other common conditions – how can you confidently diagnose this rare disorder?

Visit Cushing's Syndrome

Obesity

Learn about the complex factors influencing development of obesity.

Visit Obesity

Related Content