Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease that are not on dialysis.
Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease (CKD) that are not on dialysis.
With the U.S. FDA go-ahead Feb. 2 for GSK plc’s oral daprodustat for anemia in patients with chronic kidney disease (CKD), the picture brightened for would-be competitors in the hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor space, including high-profile Akebia Therapeutics Inc., which has appealed last spring’s the complete response letter from gatekeepers with regard to vadadustat.
Adhering to the recommendation of a mixed advisory committee vote, the U.S. FDA cleared use of GSK plc’s daprodustat as the first oral hypoxia-inducible factor prolyl hydroxylase (HIF-PHI) inhibitor for treating anemia in patients with chronic kidney disease (CKD) who are on dialysis. For CKD patients not on dialysis, the agency determined the drug’s safety has not been established.
Less than two weeks after Fibrogen Inc. received an FDA complete response letter for its hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, Evrenzo (roxadustat), Astellas Pharma Inc. and Fibrogen have won European Commission approval for the drug to treat symptomatic anemia associated with chronic kidney disease (CKD) in adults. The approval, which followed a positive CHMP opinion in June, triggered a $120 million milestone payment from Astellas to Fibrogen. In addition, Fibrogen will receive royalties on EU sales of the drug.
