New class of treatment, especially hypoxia inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to treat patients with anemia from chronic kidney disease (CKD), is gaining traction in countries where drugs of this class are approved. India is yet to approve its first HIF-PH inhibitor drug to treat anemia associated with chronic kidney disease. However, Zydus Cadila’s desidustat may become the first HIF-PH inhibitor in the country, says GlobalData, a leading data and analytics company.
Recently, Zydus Cadila has filed desidustat in India based on DREAM-ND (588 patients) and DREAM-D (392 patients) Phase III trials data in patients with CKD not on dialysis and on dialysis, respectively
Prashant Khadayate, Pharma Analyst at GlobalData, comments: “Desidustat is indigenously developed HIF-PHI and India may become the first country to approve it. The other HIF-PHI roxadustat from AstraZeneca is also in the filed stage in India. However, as per AstraZeneca India - 42nd Annual General Meeting, roxadustat is something which the company will continue to pursue from a perspective of EU. It also reflects that India is not the key priority market for roxadustat.”
According to GlobalData’s Pharma Intelligence Center, the diagnosed prevalent cases of chronic kidney disease anemia in India are projected to increase from 5.3 million cases in 2020 to 6.5 million cases in 2029, equating to an annual growth rate of 2.71%.
The CKD anemia market is relatively well-established with existing therapies, namely erythropoiesis-stimulating agents (ESAs), effectively controlling anemia in most patients. However, there is still room for improvement and innovation within the CKD anemia treatment space.
While ESAs have improved the treatment for patients with CKD anemia, their safety profiles are not ideal. As injectable ESAs often stimulate erythropoietin to supraphysiologic levels, which subsequently associate their use with increased cardiovascular risks, safer treatment options for CKD anemia are currently the most significant unmet need for the condition.
Furthermore, with dosing often required multiple times a week, their subcutaneous and intravenous routes of administration represent a burden to patients, and oral or other patient-friendlier options were also identified as an unmet need. HIF-PHIs, the first oral options for CKD anemia patients, are being formulated to help address such issues.
Khadayate concludes: “Desidustat penetration in India is expected to be high as trials were executed and physicians rely more on trials data from India. Considering the commercial strength of Zydus Cadila in India, the company needs to ensure that majority of the patients benefit from this novel treatment.”
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