Amgen Inc has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for denosumab, an investigational RANK Ligand inhibitor. The indications for which Amgen is seeking FDA approval are treatment and prevention of postmenopausal osteoporosis (PMO) in women, and treatment and prevention of bone loss in patients undergoing hormone ablation for either prostate or breast cancer. The BLA submission contains data from six phase-3 trials involving more than 11,000 patients.

"Two phase-3 pivotal studies with fracture endpoints, in the PMO and prostate cancer settings, demonstrated denosumab's ability to reduce fracture, and all six studies showed denosumab's ability to increase bone mineral density at all skeletal sites measured," said Roger M Perlmutter, executive vice president of Research and Development at Amgen. "Today's submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies."

Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications.

Postmenopausal osteoporosis affects more than 200 million people worldwide, and can have devastating consequences. In the US, one in two women over the age of 50 will fracture in her lifetime, and one third of those who fracture will break another bone within one year. Osteoporotic fractures cost the US healthcare system more than $20 billion annually, equivalent to the cost associated with cardiovascular disease and asthma. It has been reported that osteoporosis results in more hospital bed-days than stroke, myocardial infarction or breast cancer.

In the US, prostate cancer is the most common cancer in men and breast cancer is the most common cancer in women. It is common for prostate cancer and breast cancer patients to receive hormone ablation therapies that can lead to a decrease in bone mass and increased risk of fractures. Currently there are no approved therapies for bone loss in patients undergoing hormone ablation for either 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).

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