Amgen's Denosumab: Quick Takes from FDA's Advisory Committee Meeting
This article was originally published in RPM Report
FDA’s Reproductive Health Products Advisory Committee meeting on Amgen’s osteoporosis drug could have derailed denosumab’s prospects at a number of key turning points. But Amgen’s presentation combined with the drug’s effi cacy profi le pushed the investigational product through a key regulatory toll gate relatively unscathed.
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An FDA panel was convened to re-evaluate the cardiovascular risks associated with Amgen’s Aranesp and the ESAs after a third clinical trial showed CV endpoints going in a negative direction. The company was able to emerge from the meeting with a near-best case scenario. That’s critical with a CMS coverage decision looming.
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.
A year ago, Congress sent FDA two very clear, somewhat contradictory messages: Hold more advisory committee meetings, but without the use of many expert panelists used in the past. The result is a system that is stretched to the limits.