Astrazeneca (AZ) may soon seek regulatory clearance for the commercialisation of the company’s anaemia drug roxadustat in India.
Roxadustat, a first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), is currently approved in China to treat anaemia in chronic kidney disease (CKD) patients. The drug has also received approval in Japan for the treatment of dialysis patients with anaemia from CKD.
The company is now in the process of submitting a regulatory filing in the US for the indication. Application for marketing approval for will be submitted soon after getting regulatory clearance in the US.
“We have been in discussions with the Indian regulatory agencies and once the regulatory filing in the US is submitted, we will focus on submissions in other countries across the globe including India,”, said John Houghton, Global Medicine Leader at AstraZeneca.
AstraZeneca expects to complete the regulatory submission in the US in the fourth quarter of 2019.
AZ in partnership with Fibrogen is working towards development and commercialisation of roxadustat in the US, China, and other global markets. reported the company.
Through a unique mechanism of action, roxadustat acts by mimicking the body’s natural response to hypoxia by promoting erythropoiesis through increasing the endogenous production of erythropoietin. This improves the iron regulation and helps overcome the negative impact of inflammation on haemoglobin synthesis and red blood cell production by downregulating hepcidin.
In clinical study, use of roxadustat has been shown to induce coordinated erythropoiesis, increasing red blood cell count while maintaining plasma erythropoietin levels within or near normal physiologic range, in multiple subpopulations of CKD patients, including in the presence of inflammation and without a need for supplemental IV iron.
The efficacy data of roxadustat from the Phase III OLYMPUS and ROCKIES trials, as well as pooled efficacy and cardiovascular (CV) safety data from the Phase III global programme was presented by the company at the American Society of Nephrology (ASN) Kidney Week 2019 meeting, held recently.
Patients with anaemia from CKD have significant CV risk when compared to a healthy population. The risk increases as kidney function declines in later stages of disease. When treating anaemia from CKD, it is important to consider a therapeutic approach that increases haemoglobin and decreases anaemia whilst not further increasing the CV risk.
The pooled analyses of the Phase III programme assessing roxadustat showed positive efficacy and no increased CV risk in patients with anaemia from CKD versus comparators.
In non-dialysis-dependent (NDD) patients receiving roxadustat, the risk of major adverse CV events (MACE), MACE+ ( MACE with unstable angina requiring hospitalisation and congestive heart failure requiring hospitalisation)and all-cause mortality was reported to be comparable to placebo.
In dialysis-dependent (DD) patients, patients receiving roxadustat reported a lower risk of MACE+ and no increased risk of MACE or all-cause mortality versus epoetin alfa, a current medicine used to treat anaemia.
In a clinically important predefined subgroup of incident dialysis (ID) patients, roxadustat reduced the risk of MACE and MACE+ . The results showed a trend towards lower risk of all-cause mortality relative to epoetin alfa, announced the researchers.
Enabling for an individualised approach for each patient, the dosing regimen of roxadustat would vary based on the patients CKD, said the company.
“Patients with anaemia from CKD have seen little to no innovation in decades. We feel confident in the potential of roxadustat as a promising new treatment option for patients with anaemia from CKD as it mimics the body’s natural response to hypoxia.” says Houghton.