Amgen Inc announced that the US Food and Drug Administration (FDA) has asked the company to participate in a meeting of the Reproductive Health Drugs Advisory Committee (RHDAC) on August 13, 2009. The RHDAC will review data supporting the Biologics License Application (BLA) for denosumab, a RANK Ligand inhibitor for which Amgen is seeking approval for prevention and treatment of postmenopausal osteoporosis and prevention and treatment of bone loss in patients undergoing hormone ablation for either prostate or breast cancer.

"In the US, one woman in two over the age of 50 will experience an osteoporotic fracture in her remaining lifetime. Although osteoporosis treatments are available, there remains a need for other options that deliver robust efficacy and support adherence to therapy," said Sean Harper, chief medical officer and head of Global Development at Amgen. "Likewise, there is currently no approved treatment for the men and women receiving hormone ablation therapy for prostate or breast cancer who are at increased risk for bone loss and consequently fracture. We look forward to discussing the data from our denosumab trials in these settings with the members of the committee."

Amgen's BLA submission contains data from six phase-3 trials involving more than 11,000 patients and approximately 13,000 patient years of exposure to denosumab. Two phase-3 pivotal studies with fracture endpoints, in the osteoporosis and prostate cancer settings, demonstrated denosumab's ability to reduce the incidence of fractures, and all six studies showed denosumab's ability to increase bone mineral density at all skeletal sites measured. In the two pivotal studies with fracture endpoints, the incidence and types of adverse events with denosumab were similar to placebo. The most common adverse events in both the denosumab and placebo groups were arthralgia, back pain, hypertension, nasopharyngitis, constipation and pain in extremity.

The FDA has provisionally approved the trade name Prolia for denosumab in the proposed indications of treatment and prevention of osteoporosis in postmenopausal women, and treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer.

Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, an essential regulator of osteoclasts (the cells that break down bone).

Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient.