Anemia Drug Rejected by FDA Wins EU Approval

Astellas Pharma and Fibrogen have received EU approval for Evrenzo (roxadustat) for treating adults with anemia associated with chronic kidney disease (CKD) — mere days after the FDA rejected the drug for the same indication in the U.S.

The episode marks a rare moment of regulatory discord between the health agencies. The European Medicines Agency’s Committee for Medicinal Products for Human Use gave the drug the thumbs up in June after evaluating the drugmakers’ pivotal phase 3 program. That led to the EU’s approval last week. For its part, the FDA called for additional study data in rejecting the drug, likely tied to safety concerns brought up by the agency’s advisory committee at a meeting last month.

And with this approval, Evrenzo becomes the first oral hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) enzyme inhibitor to be approved for EU use, beating out GlaxoSmithKline, which recently touted positive topline phase 3 results for its investigational CKD-linked anemia drug daprodustat.

HIF-PH inhibitors work by activating the body’s natural response to lowered blood oxygen levels and reduces the need for injectable red blood cell stimulating agents that are usually administered with intravenous iron to combat anemia.