12.22.08
Amgen has submitted a Biologics License Application (BLA) with the FDA for denosumab, an investigational RANK Ligand inhibitor. Amgen is seeking 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 contains data from six Phase III trials involving more than 11,000 patients, according to Amgen.
"Two Phase III 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 R&D at Amgen. "This 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.
"Two Phase III 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 R&D at Amgen. "This 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.