Posted by Michael Wonder on 10 Oct 2017
FDA accepts supplemental biologics license application for Prolia (denosumab) in glucocorticoid-induced osteoporosis
9 October 2017 - Glucocorticoid-induced osteoporosis is the most common form of secondary osteoporosis.
Amgen today announced that the U.S. FDA has accepted for review the supplemental biologics license application for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis.
The application, which was submitted on 28 July 2017, is based on a Phase 3 study evaluating Prolia compared with risedronate in patients receiving glucocorticoid treatment. The FDA has set a Prescription Drug User Fee Act action date of 28 May 2018.
