New Delhi: Pharmaceutical major AstraZeneca has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) to import and market the anti-diabetic drug Dapagliflozin for the additional indication, to reduce the risk of sustained Estimated Glomerular Filtration Rate (e-GFR) and kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression.

However, this approval is subjected to the condition that the drug is indicated in adults for the treatment of patients with chronic kidney disease (CKD) up to an estimated glomerular filtration rate (eGFR) of greater than or equal to 25 ml/min/1.73m2.

The expert panel further recommended that patients may continue taking 10 mg orally once daily to lower their risk of eGFR decrease, end-stage kidney disease (ESKD), cardiovascular (CV) mortality, and hypertensive heart failure (hHF). However, treatment initiation is not advised for those whose estimated glomerular filtration rate (eGFR) is lower than 25 ml/min/1.73m2.

This came after the firm presented the application for import and marketing permission of Dapagliflozin film-coated tablets 10 mg for the additional indication “to reduce the risk of sustained e-GFR and kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression”.

Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor used in the management of type 2 diabetes mellitus. Dapagliflozin inhibits the sodium-glucose contransporter 2 (SGLT2), which is primarily located in the proximal tubule of the nephron. SGLT2 facilitates 90% of glucose resorption in the kidneys and so its inhibition allows for glucose to be excreted in the urine. This excretion allows for better glycemic control and potentially weight loss in patients with type 2 diabetes mellitus.

At the recent SEC meeting for Cardiovascular and Renal held on October 11th,2022, the expert panel extensively reviewed the proposal presented by the drug maker AstraZeneca to import and market the anti-diabetic drug Dapagliflozin film-coated 10mg for the additional indication ‘to reduce the risk of sustained e-GFR and kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression”.
After detailed deliberation, the committee recommended the grant of additional indication ” to reduce the risk of sustained eGFR and kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression” with condition that: – It is indicated in adults for the treatment of patients of Chronic Kidney Disease (CKD) up to eGFR of greater than or equal to 25 ml/min/1.73m2. Below this, initiation of the treatment is not recommended, however, the patients may continue 10 mg orally once daily to reduce the risk of eGFR decline, ESKD, CV death, and hHF.

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