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FibroGen’s Roxadustat Faces US FDA Scrutiny On ‘Prominent’ Safety Signals Relative To Erythropoietin

Executive Summary

Risks of serious thrombotic events, seizures and infection make the benefits of the first-in-class oral drug for treating anemia related to chronic kidney disease ‘difficult to calculate’ despite demonstrated improvements in hemoglobin, FDA says in advisory committee briefing document.

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FibroGen’s Roxadustat Rejected By US FDA Panel Due To Safety Concerns, Untested Dosing Strategy

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.

EU CHMP Opinions and MAA Updates

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.

Keeping Track: Cloudy Horizon For Teplizumab, Roxadustat; Nuplazid Stumbles Over Subgroups; CAR-T Submissions From Gilead, J&J

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

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