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.
Anemia is a common complication of chronic kidney disease (CKD). It is associated with significant morbidity, mortality, progression of kidney disease in patients with diabetes, and higher transfusion rates in the CKD population. Desidustat exerts inhibition of prolyl hydroxylase domain,activating HIF signaling and represents effective treatments of anemia in CKD. Desidustat has also been shown to prevent acute respiratory distress syndrome (ARDS) by inhibiting IL-6.
At the recent SEC meeting for Cardiovascular and Renal held on 19.07.2022, the expert panel reviewed the proposal for manufacturing and marketing of the Desidustat Tablet 100mg for the treatment of Anaemia in adult patients with chronic kidney disease (CKD) not on dialysis and on dialysis with the justification of BE study waiver.
After detailed deliberation, the committee recommended for grant of permission for manufacturing and marketing of the Desidustat Tablets 100 mg for already approved indication.
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