The U.S. Food and Drug Administration agreed to review Amgen’s supplemental biologics license application for Prolia (denosumab), a drug targeting patients with glucocorticoid-induced osteoporosis (GIOP), an Amgen release said.
Amgen said in the release the FDA set an date of May 28, 2018, to issue a Prescription Drug User (PDUFA) action.
"We believe that Prolia can address a critical treatment need for patients with glucocorticoid-induced osteoporosis, which is the most common drug-induced form of the disease," Amgen Executive Vice President of Research and Development Sean Harper said in the release. "We will continue to work closely with the FDA as they review our application and look forward to expanding Prolia's benefits to patients with this serious condition that is often underestimated and untreated."
Prolia is designed to help patients who are taking glucocorticoid medications used to treat inflammatory conditions, the release said. According to Amgen, Prolia is indicated for treatment of postmenopausal women with osteoporosis who are at high risk for fracture and to increase bone mass in men with osteoporosis.