European CHMP announces positive opinion for Amgen's Prolia marketing authorization

Dec 18 2009

Amgen Inc. (Nasdaq: AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced a positive opinion for the marketing authorization of Prolia((TM)) (denosumab) for the treatment of osteoporosis in postmenopausal women at increased risk of fractures, and for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures. If approved by the European Commission, Amgen would receive marketing authorization for Prolia in all European Union (EU) Member States.

"Nearly two decades ago, Amgen researchers described a fundamental biochemical pathway that controls bone remodeling," said Roger M. Perlmutter, executive vice president of Research and Development at Amgen. "Armed with this information, our scientists identified a targeted therapy that acts via this normal control mechanism to reduce bone loss. Today's announcement by the CHMP offers the hope that this important new therapy will soon be available to European women with post menopausal osteoporosis, and to European men with prostate cancer who, as a result of hormone ablation therapy, have a significantly increased risk of fracture. With its ability to significantly reduce fractures at key skeletal sites throughout the body, a favorable benefit-risk profile, and convenient dosing every six months, Prolia addresses an important unmet medical need."

The CHMP positive opinion is based on data from six Phase 3 trials. Two Phase 3 pivotal studies with fracture endpoints in the osteoporosis and prostate cancer settings demonstrated that Prolia administered as a subcutaneous injection twice yearly (60mg) reduces the incidence of fractures. All six studies showed Prolia's ability to increase bone mineral density at all skeletal sites measured.

Results from the pivotal FREEDOM (Fracture REduction Evaluation of Denosumab in Osteoporosis every six Months) study in 7,868 women with postmenopausal osteoporosis showed that women receiving a subcutaneous injection of Prolia twice-yearly experienced a 68 percent reduction in the risk of suffering a new vertebral (spine) fracture compared to those receiving placebo, as well as a 40 percent reduction in the risk of suffering a hip fracture and a 20 percent reduction in the risk of suffering a nonvertebral fracture. Results from the pivotal Hormone AbLation Therapy study in 1,468 men undergoing androgen deprivation therapy (ADT) for non-metastatic prostate cancer showed that patients treated with Prolia experienced a 62 percent reduction in the risk of suffering a new vertebral fracture with Prolia compared to placebo at 36 months, with significant reduction observed as early as month 12. In both pivotal studies, the incidence and types of adverse reactions observed with Prolia were similar to those seen in patients taking a placebo. The most common adverse reactions in both the Prolia and placebo groups were arthralgia, back pain, hypertension, nasopharyngitis, constipation and pain in an extremity. Serious adverse reactions of skin infections, predominantly cellulitis, were reported more commonly in the Prolia group (0.4 percent vs. <0.1 percent) in postmenopausal osteoporosis studies. In breast and prostate cancer studies, serious adverse reactions were similar in the Prolia and placebo groups (0.6 percent vs. 0.6 percent).

Prolia is also under regulatory review in the United States (U.S.), Switzerland, Australia and Canada for the treatment and prevention of postmenopausal osteoporosis and for the treatment of bone loss in patients undergoing hormone ablation therapy for breast or prostate cancer.