Zydus Life Desidustat gets CDSCO panel nod to treat Anaemia in Kidney Patients
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New Delhi: In a significant development, Zydus Life has received approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to manufacture and market Desidustat Tablet for the treatment of Anaemia in adult patients with chronic kidney disease(CKD).
This came in line with proposal presented by the drug maker Zydus Life to manufacture and market the Desidustat Tablets 100 mg for the treatment of Anaemia in adult patients with chronic kidney disease(CKD) not on dialysis and on dialysis along with the justification of Bioequivalence (BE) study waiver.
Desidustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor( HIF - PH Inhibitors). These are a new class of agents used in the treatment of anemia in Chronic Kidney Disease. These agents work by stabilizing the HIF complex and stimulating endogenous erythropoietin production even in patients with end-stage kidney disease. Desidustat reduces the need for recombinant erythropoietin (EPO) requirement in anemia, and decreases EPO resistance, by reducing IL-6, IL-1β, and anti-EPO antibodies.
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