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|Amgen Announces 23 Abstracts To Be Presented At The American Society for Bone and Mineral Research 2014 Annual Meeting|
Prolia data consist of 18 abstracts, including several exploratory analyses evaluating eight years of Prolia therapy from the open-label extension study of the pivotal Phase 3 fracture trial. Analyses report the percentage of women who achieved non-osteoporotic bone mineral density (BMD) T-scores and the long-term effects of Prolia on reducing cortical bone loss. A separate analysis reports compliance and persistence among women at high risk of fracture identified in a commercially-insured database. Data for romosozumab include two exploratory analyses from the Phase 2 trial and open-label extension study in postmenopausal women with low BMD. The first analysis evaluated the effect of treatment with romosozumab over two years, as well as data on a third year where patients received either Prolia or placebo; another examined the effect of romosozumab treatment on vertebral cortical mass, thickness and density. Romosozumab is being co-developed by
"Given that more than 200 million women worldwide have osteoporosis,1 and many of these have experienced a fracture, additional therapies are needed to help manage the continuum of the disease," said
SELECTED ABSTRACTS OF INTEREST
Prolia Abstracts of Interest
Romosozumab Abstracts of Interest
About half of all women over age 50 will have an osteoporosis-related fracture in their remaining lifetime.3 Only 24 percent of women who suffer an osteoporotic fracture received treatment during the following year.4
The World Health Organization has officially declared osteoporosis a public health crisis, while the International Osteoporosis Foundation urges governments worldwide to make osteoporosis a healthcare priority.
About Prolia® (denosumab)
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. 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 approved in the EU plus
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 nonmetastatic prostate cancer.
Prolia is administered as a single subcutaneous injection of 60 mg once every six months. For further information on Prolia, including prescribing information and medication guide, please visit: www.prolia.com.
Important U.S. Safety Information
Clinically significant hypersensitivity including anaphylaxis has been reported with Prolia. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of Prolia. Hypocalcemia may worsen with the use of Prolia, especially in patients with severe renal impairment. All patients should be adequately supplemented with calcium and vitamin D.
Osteonecrosis of the jaw (ONJ) and atypical femoral fractures have been reported in patients with Prolia. In the pivotal Phase 3 study of women with postmenopausal osteoporosis (n=7,808), serious infections leading to hospitalizations were reported more frequently in the Prolia-treated patient group. Serious skin infections, as well as infections of the abdomen, urinary tract and ear, were more frequent in patients treated with Prolia. Patients should be advised to seek prompt medical attention if they develop signs or symptoms of severe infection, including cellulitis. Epidermal and dermal adverse events such as dermatitis, rashes and eczema have been reported. Discontinuation of Prolia should be considered if severe symptoms develop.
Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported. In clinical trials in women with postmenopausal osteoporosis, Prolia resulted in significant suppression of bone remodeling. The significance of these findings is unknown. The long-term consequences of the degree of suppression of bone remodeling observed with Prolia may contribute to adverse outcomes such as ONJ, atypical fractures and delayed fracture healing. The most common adverse reactions (>5 percent and more common than placebo) in patients with postmenopausal osteoporosis were back pain, pain in extremity, musculoskeletal pain, hypercholesterolemia and cystitis. The most common adverse reactions in men with osteoporosis were back pain, arthralgia and nasopharyngitis. Pancreatitis has also been reported with Prolia in patients with osteoporosis. The most common (per patient incidence >10 percent) adverse reactions reported with Prolia in patients with bone loss receiving androgen deprivation therapy for prostate cancer or adjuvant aromatase inhibitor therapy for breast cancer are arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials.
The extent to which Prolia is present in seminal fluid is unknown. For men treated with Prolia, there is a potential for fetal exposure if the sexual partner is pregnant. While the risk is likely to be low, patients should be advised of this potential risk.
Important EU Safety Information
Prolia may rarely lead to hypocalcaemia. Prolia is contraindicated in patients with hypocalcaemia, and pre-existing hypocalcaemia must be corrected by adequate intake of calcium and vitamin D before initiating therapy. Patients with severe renal impairment or receiving dialysis are at greater risk of developing hypocalcaemia. In the post-marketing setting, rare cases of severe symptomatic hypocalcaemia have been predominantly reported in patients at increased risk of hypocalcaemia, with most cases occurring in the first weeks of initiating therapy. Osteonecrosis of the jaw (ONJ) has been reported rarely in clinical studies in patients receiving denosumab at a dose of 60 mg every 6 months for osteoporosis. In the osteoporosis clinical trial program, atypical femoral fractures were reported rarely in patients treated with Prolia. In the post-marketing setting, rare events of drug-related hypersensitivity, including anaphylactic reaction, have been reported in patients receiving Prolia. Hypersensitivity to the active substance or any of the excipients is a contraindication for Prolia.
Prolia is not recommended for use in pregnant women.
Denosumab Commercialization Collaboration
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