December 23, 2008 - Amgen has submitted a Biologics License Application (BLA) with the FDA for denosumab, an investigational RANK Ligand inhibitor, as Amgen seeks FDA approval for 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, M.D., Ph.D., executive vice president of Research and Development at Amgen.
Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications.
According to the American Cancer Society, in the U.S., 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.
For more information: www.amgen.com