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news.Amgen has announced the submission of a biologics license application with the FDA for denosumab, an investigational RANK ligand inhibitor.
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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 biologics license application submission is expected to contain data from six Phase III trials involving more than 11,000 patients, the company said.
Amgen also intends to submit a marketing application shortly in the European Union, Switzerland, Canada and Australia for use of denosumab in these indications.
Roger Perlmutter, executive vice president of R&D at Amgen, said: 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. 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.