Amgen is seeking approval for an additional indication in glucocorticoid-induced osteoporosis for its blockbuster osteoporosis therapeutic, Prolia.
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
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
British Patient Capital Invests £10 Million in Maxion Therapeutics, Part of Series A Financing Round
March 27th 2025The £10 million (US$13 million) investment is part of a larger £58 million (US$75 million) Series A financing round to be used for the development of Maxion Therapeutics’ preclinical lead program for treating inflammatory diseases.