European Commission Approves Prolia® (denosumab) for Patients With Glucocorticoid-Induced Osteoporosis

Third Indication in Europe for Prolia for the Treatment of Patients at Increased Risk of Fractures

THOUSAND OAKS, CA, USA I June 8, 2018 I Amgen (NASDAQ: AMGN) today announced that the European Commission (EC) has approved a new indication for Prolia® (denosumab) for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. The EC approval is based on the positive results of a Phase 3 study that evaluated the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.1

"We are pleased that today's EC approval provides physicians with a new treatment option for bone loss associated with the use of glucocorticoid medications," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "As a leader in bone health with more than 20 years of osteoporosis research experience, we believe that Prolia can address a critical treatment need for patients with glucocorticoid-induced osteoporosis in Europe and globally."

"Long-term glucocorticoid therapy is associated with a rapid and early decline in bone mineral density and increase in fracture risk," said Professor Dr. Willem F. Lems, researcher and rheumatologist, VU University Medical Centre, Amsterdam. "This approval provides a new treatment option to effectively counter the detrimental effects of glucocorticoid therapy on bone in patients at increased risk of fracture."

The EC approval is supported by a Phase 3 randomized, double-blind, double-dummy, active-controlled study evaluating the safety and efficacy of Prolia compared with risedronate in patients receiving glucocorticoid treatment.1 The study included two patient groups: those on sustained glucocorticoid therapy and those newly initiating glucocorticoid therapy. The study met the primary endpoint (percent change from baseline in lumbar spine bone mass density [BMD] at 12 months, assessing non-inferiority) and all secondary endpoints (the percent changes from baseline in lumbar spine and total hip BMD at 12 and 24 months, assessing superiority).

In the glucocorticoid-continuing subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at one year (Prolia 3.6 percent, risedronate 2.0 percent; p<0.001) and two years (Prolia 4.5 percent, risedronate 2.2 percent; p<0.001). In the glucocorticoid-initiating subpopulation, Prolia demonstrated a greater increase in lumbar spine BMD compared to risedronate at one year (Prolia 3.1 percent, risedronate 0.8 percent; p<0.001) and two years (Prolia 4.6 percent, risedronate 1.5 percent; p<0.001).

In addition, compared with risedronate, Prolia demonstrated significantly greater mean percent increases in BMD from baseline at one and two years at the total hip, femoral neck and trochanter in both the glucocorticoid-continuing and glucocorticoid-initiating subpopulations. Adverse events and serious adverse events were similar between treatment groups and consistent with the known safety profile of Prolia. No serious adverse events were reported with a subject incidence of two percent or greater in either treatment group.

The U.S. Food and Drug Administration (FDA) approved the expanded indication of Prolia for the treatment of osteoporosis associated with newly initiating or sustained systemic glucocorticoid therapy in men and women at high risk of fracture on May 18, 2018.

About Glucocorticoid-Induced Osteoporosis (GIOP)
GIOP is the most common form of secondary osteoporosis.However, the proportion of patients that qualify for GIOP diagnosis and intervention is small and depends on the level of exposure to glucocorticoid medications.3,4 In addition, a significant proportion of the patients treated long-term with glucocorticoid medications are already diagnosed with postmenopausal osteoporosis or treated with osteoporosis medications. Importantly, at similar levels of BMD, postmenopausal women taking glucocorticoids have considerably higher risk of fracture compared with postmenopausal nonusers of glucocorticoids.The most frequent chronic inflammatory diseases associated with long-term glucocorticoid use are chronic obstructive pulmonary disorder (COPD), asthma and rheumatoid arthritis. In an European Union (EU) study, 30 to 40 percent of patients on long-term glucocorticoid treatment had radiographic evidence of vertebral fractures.6

About Prolia® (denosumab)
Prolia is the first approved therapy that specifically targets RANK Ligand, an essential regulator of bone-removing cells (osteoclasts). Prolia is approved and marketed in over 80 countries worldwide.

Prolia is approved in the U.S. 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 the U.S., Prolia is also approved 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 also indicated as a treatment to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer and in men at high risk for fracture receiving androgen deprivation therapy for non-metastatic prostate cancer in the U.S. Prolia was approved by the FDA on May 18, 2018, as a treatment for patients with glucocorticoid-induced osteoporosis in men and women at high risk of fracture who are either initiating or continuing systemic glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and expected to remain on glucocorticoids for at least six months. High risk of fracture is defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

Prolia is approved in the EU for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures. In postmenopausal women, Prolia significantly reduces the risk of vertebral, non-vertebral and hip fractures.  

In the EU, Prolia is also approved for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. In men with prostate cancer receiving hormone ablation, Prolia significantly reduces the risk of vertebral fractures.

Prolia is also approved in the EU for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture.

Prolia is administered as a single subcutaneous injection of 60 mg once every six months. Please see the Important Safety Information below.

Denosumab is a human monoclonal antibody. As with all therapeutic proteins, there is potential for immunogenicity.

For more information, please see the Prolia® Prescribing Information and Medication Guide.

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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

References

1 Saag KG, Wagman RB, Geusens P, Adachi JD, Messina OD, Emkey R, Chapurlat R, Wang A, Pannacciulli N, Lems WF. Denosumab versus risedronate in glucocorticoid-induced osteoporosis: a multicentre, randomised, double-blind, active-controlled, double-dummy, non-inferiority study. Lancet Diabetes Endocrinol. 2018 Apr 6. pii: S2213-8587(18)30075-5.
2 Briot K, Roux C. Glucocorticoid-induced osteoporosis. RMD Open. 2015;1:e000014.
3 Buckley L, et al. Arthritis Care Res (Hoboken). 2017;69:1095–1110.
4 Lekamwasam S, et al. Osteoporos Int. 2012;23:2257-2276.
5 van Staa TP, et al. Bone density threshold and other predictors of vertebral fracture in patients receiving oral glucocorticoid therapy. Arthritis Rheum 2003;48:3224-3229.
6 Angeli A, Guglielmi G, Dovio A, Capelli G, de Feo D, Giannini S, et al. High prevalence of asymptomatic vertebral fractures in post-menopausal women receiving chronic glucocorticoid therapy: a cross-sectional outpatient study. Bone. 2006;39:253-9.

SOURCE: Amgen

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