Posted by Michael Wonder on 31 Jul 2017
Amgen submits supplemental biologics license application for Prolia (denosumab) in glucocorticoid-induced osteoporosis
31 July 2017 - Amgen today announced the submission of a supplemental biologics license application to the U.S. FDA for Prolia (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis.
The application is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.
