Ellis Unger’s US FDA Farewell Address?
The US FDA advisory committee review of AstraZeneca/FibroGen’s roxadustat for anemia was the last in the long tenure of Office of Cardiology Director Ellis Unger. His opening remarks struck a valedictory tone.
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But advisory committee members see a potential opportunity for the oral anemia drug in small percentage of dialysis-dependent patients not responsive to erythropoiesis-stimulating agents; FibroGen’s revised dosing algorithm, aimed at slowing hemoglobin rate of increase and reducing risk of thrombosis, needs to be clinically tested before marketing approval, panelists said.
Latest iteration of the Prescription Drug User Fee Act agreement negotiated by US FDA and the pharmaceutical industry continues the trend to ever larger sets of goals and commitments as part of the reauthorization process.
Not only does the CBO’s new model make the impact of draconian changes look small, it also gives a framework for compromise that could make legislation more likely to pass Congress.