Feb. 11, 2020: FibroGen announced that the U.S.FDA has completed its filing review of its New Drug Application (NDA) for roxadustat for the treatment of anemia of chronic kidney disease (CKD), both in non-dialysis-dependent (NDD) and dialysis-dependent (DD) patients. The application will be measured filed on Feb. 18, 2020. The FDA has set a Prescription Drug User Fee Act (PDUFA) date of the December 20, 2020.
“The FDA’s acceptance of the roxadustat NDA is the critical step towards as long as a new treatment option in the United States for the chronic kidney disease patients suffering from anemia, a severe and often life-threatening disease,” said Enrique Conterno, Chief Executive Officer, FibroGen.
The filing of the roxadustat NDA triggers $50 million milestone payment from AstraZeneca to FibroGen. Roxadustat is the first small molecule hypoxia-inducible factor prolyl hydroxylase (HIFPH)orally administered inhibitor approved by the FDA for the treatment of CKD anaemia.The submission is supported by positive results from the global Phase 3 program encircling more than 8,000 patients.
Roxadustat is currently approved in China for the treatment of anemia in the patients with CKD, regardless of whether they necessitate dialysis, and in Japan for the treatment of dialysis patients with anemia of the CKD.FibroGen’s partner Astellas also plans to file an application for marketing authorisation with the European Medicines Agency in the first half of 2020.
About Anemia Associated with CKD: Anemia results from the reduced oxygen-carrying capacity of the blood, in which patients usually have insufficient red blood cells and/or low levels of the hemoglobin, a protein in red blood cells that carries oxygen to cells all the way through the body. CKD anemia, which can be associated with the increased risk of hospitalization, cardiovascular complications, and death, also recurrently causes significant fatigue, cognitive dysfunction, and reduced quality of the life. Severe anemia is common in patients with the CKD, cancer, myelodysplastic syndromes (MDS), inflammatory diseases, and other severe illnesses.
https://fda.einnews.com/pr_news/509481763/fibrogen-announces-u-s-fda-acceptance-of-new-drug-application-for-roxadustat-for-the-treatment-of-anemia-of-chronic-kidney-diseases
