Amgen Submits Supplemental Biologics License Application For Prolia® (denosumab) In Glucocorticoid-Induced Osteoporosis

THOUSAND OAKS, CA, USA I July 31, 2017 I Amgen (NASDAQ:AMGN) today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for Prolia® (denosumab) for the treatment of patients with glucocorticoid-induced osteoporosis (GIOP).The sBLA is based on a Phase 3 study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.

Osteoporosis can be caused by glucocorticoid medications, which are prescribed to treat inflammatory diseases. Within the first three months of beginning glucocorticoid treatment, fracture risk increases by up to 75 percent, with bone mineral density (BMD) continuing to decline significantly in the months that follow.1

"Glucocorticoid-induced osteoporosis can lead to weakened bones and debilitating fractures," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "With this submission and future approval, we look forward to bringing the benefits of Prolia to patients living with this often overlooked and untreated form of osteoporosis."

Results from the Phase 3 study included in the sBLA submission showed that treatment with Prolia for 12 months led to statistically significant greater gains in BMD at the lumbar spine and total hip compared to risedronate, both in patients on sustained glucocorticoid therapy and in those newly initiating glucocorticoid therapy. Adverse events (AEs) and serious adverse events (SAEs) were similar across treatment groups and consistent with the known safety profile of Prolia.     

About Prolia® (denosumab) 
Prolia is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, Prolia reduces the incidence of vertebral, nonvertebral, and hip fractures.

Prolia is indicated for treatment to increase bone mass in men with osteoporosis at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia is indicated as a treatment to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer. In these patients Prolia also reduced the incidence of vertebral fractures.

Prolia is indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

SOURCE: Amgen

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