FDA Accepts Amgen’s Application for New Indication of Osteoporosis Biologic

FDA has accepted for review a supplemental biologics license application (sBLA) filed by Amgen for its osteoporosis drug, Prolia (denosumab), seeking approval for treating glucocorticoid-induced osteoporosis (GIOP), Amgen announced on Oct. 9, 2017. Prolia, approved by FDA in 2010, is among Amgen’s top-selling products with 2016 sales of more than $1.6 billion.

The sBLA was submitted on July 28, 2017, and FDA has set a Prescription Drug User Fee Act action date of May 28, 2018. GIOP is the most common form of secondary osteoporosis.

"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," said Sean E. Harper, MD, executive vice president of Research and Development at Amgen, in a company press release. "We will continue to work closely with [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 indicated for treating osteoporosis in postmenopausal women. It is also indicated for increasing bone mass in men with osteoporosis at high risk for fracture and for increasing bone mass in women undergoing breast cancer treatment who are at high risk for fracture.

Source: Amgen