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Amgen receives FDA approval to expand use of Prolia (denosumab) to patients with Glucocorticoid-Induced Osteoporosis

US regulators have approved a new indication for Amgen’s Prolia, allowing its use to treat glucocorticoid-induced osteoporosis (GIOP) in men and women at high risk of fracture.

The decision allows physicians to prescribe the drug to patients with a history of osteoporotic fracture, those with multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy.

GIOP is caused by taking glucocorticoid medicines which are commonly used to treat inflammatory diseases. Within the first three months of treatment, patient fracture risk increases up to 75 percent, although BMD will continue to decline significantly in the months to follow.

“This is a serious condition that leads to rapid decreases in bone mineral density and increased risk of fracture. This approval gives patients and physicians a new treatment option,” noted Sean E. Harper, executive vice president of Research and Development at Amgen.

Glucocorticoid medications, which are used to treat many inflammatory conditions such as chronic obstructive pulmonary disorder (COPD), asthma, multiple sclerosis and rheumatoid arthritis, can cause significant side effects, including bone loss.

GIOP is the most common form of secondary osteoporosis. However, the proportion of patients that qualify for GIOP diagnosis and intervention is very small and depends on the level of exposure to glucocorticoid medications. 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 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. More than 10 percent of patients who receive long-term glucocorticoid treatment are diagnosed with a clinical fracture, and 30 to 40 percent have radiographic evidence of vertebral fractures.

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 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.

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 administered as a single subcutaneous injection of 60 mg once every six months.

Please refer to product information leaflet for important safety information regarding Prolia.

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