Amgen stated Monday that the FDA’s Reproductive Health Drugs Advisory Committee is scheduled to review data for denosumab on August 13. The company is seeking approval of the drug for the prevention and treatment of postmenopausal osteoporosis, and to prevent and treat bone loss in patients undergoing hormone ablation for either prostate or breast cancer.

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The FDA is scheduled to render a verdict on the RANK Ligand inhibitor by October, and if approved, it is expected to be sold under the brand name Prolia. Amgen noted that the regulatory submission for denosumab contains data from six late-stage trials involving more than 11 000 patients. The drugmaker said all six trials demonstrated denosumab’s ability to increase bone mineral density at all skeletal sites that were measured.

Source: FirstWord

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