December 18, 2020: “The US FDA has requested further clarifying analyses of clinical data, to complete its review of the NDA for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anaemia of chronic kidney disease (CKD).
AstraZeneca and FibroGen, Inc. (FibroGen) are committed to working with the FDA and have agreed to submit the additional clarifying analyses as soon as possible to assist with the completion of labelling discussions.
The NDA remains under regulatory review, with the FDA having set a new action date of 20 March 2021.
Related news: U.S. FDA Acceptance of New Drug Application for FibroGen’s Roxadustat for the Treatment of Anemia of Chronic Kidney Disease
FibroGen Submits New Drug Application to the U.S. FDA for Roxadustat for the treatment of anemia of chronic kidney disease (CKD)
Anaemia
Anaemia can be a serious medical condition in which patients have insufficient red blood cells (RBCs) and low levels of haemoglobin, a protein in RBCs that carries oxygen to cells throughout the body.Â
Anaemia of CKD is associated with increased risk of hospitalisation, cardiovascular complications and death, also frequently causing significant fatigue, cognitive dysfunction and decreased quality of life.
Severe anaemia is common in patients with CKD, cancer, myelodysplastic syndrome (MDS), inflammatory diseases and other serious illnesses. Anaemia is particularly prevalent in patients with CKD.Â
CKD affects nearly 700 million patients worldwide and is generally progressive, characterised by gradual loss of kidney function that may eventually lead to kidney failure.
Roxadustat
Roxadustat, an oral medicine, is the first in a new class of medicines called HIF-PH inhibitors that promotes erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilisation, and downregulation of hepcidin.
Roxadustat is also in clinical development for anaemia associated with MDS and for chemotherapy-induced anaemia.
Roxadustat is approved in China, Japan (under the name Evrenzo), and Chile for the treatment of anaemia in CKD in non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.
In Europe, the Marketing Authorisation Application for Evrenzo for the treatment of anaemia in CKD in NDD and DD patients was submitted by Astellas Pharma Inc. (Astellas) and accepted by the European Medicines Agency for review in May 2020.
AstraZeneca and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in the US, China and other markets in the Americas, Australia and New Zealand, as well as Southeast Asia.
Astellas and FibroGen are collaborating on the development and commercialisation of roxadustat for the potential treatment of anaemia in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa.
Phase III programme
AstraZeneca, FibroGen and Astellas conducted the pivotal Phase III programme, which included more than 8,000 patients.
The OLYMPUS, ALPS and ANDES trials evaluated roxadustat compared to placebo in NDD patients.
ROCKIES, SIERRAS and HIMALAYAS, evaluated roxadustat compared to epoetin alfa in DD patients.
HIMALAYAS evaluated roxadustat compared to epoetin alfa in incident dialysis (ID) patients; there were ID patients in ROCKIES and SIERRAS.”
https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/update-on-us-regulatory-review-of-roxadustat-in-anaemia-of-chronic-kidney-disease.html
