Article preview from IN VIVO April 21, 2009
D-mab is the new EPO. At least, that's what Amgen is hoping as it awaits FDA approval for its next growth engine, denosumab (D-mab). Assuming the drug gets to market--and Amgen is very confident it will--the drug's success will depend largely on pricing. Read on...
Article preview from IN VIVO April 21, 2009 D-mab is the new EPO. At least, that's what Amgen Inc. is hoping as it awaits FDA approval for its next growth engine, denosumab (D-mab). Submitted to FDA in December 2008 (and in the EU in January 2009) for post-menopausal osteoporosis (PMO) and some cancer indications, this drug is what Amgen needs if there's to be independent life after its eroding EPO franchise, opines Jonas Alsenas, an analyst at Leerink Swann (which makes a market in Amgen).
According to Roger Perlmutter, MD, PhD, Amgen's EVP, R&D, there's no question that Amgen will have D-mab, though. Despite the uncertain regulatory climate, he's very confident in the drug's prospects. "I can't give you timing, but it's extremely unlikely that D-mab will not gain registration," he told IN VIVO.
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