Amgen files new drug application for denosumab


According to a company media release issued last Friday, Amgen has filed a second new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for approval of denosumab (a RANK-L inhibitor to be known commercially as Prolia®). This second NDA seeks approval to market denosumab for the prevention of skeletal-related events (e.g., fractures and other clinical effects) in patients with progressive forms of cancer — specifically including prostate cancer.

In February 2009, Amgen filed an initial NDA for denosumab for treatment and prevention of postmenopausal osteoporosis in women and treatment and prevention of bone loss in patients undergoing hormone ablation therapy for either prostate or breast cancer. The FDA is expected to make a decision about the approval of denosumab for these first clinical uses before the end of July 2010.

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