CDSCO approves AstraZeneca’s anti-diabetic drug Dapagliflozin

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AstraZeneca India’s anti-diabetic medication Dapagliflozin has been approved by the Central Drugs Standard Control Organization (CDSCO) for the treatment of adults with chronic kidney disease (CKD), According to Biospectrum India.

For individuals with chronic kidney disease that is progressing, dapagliflozin is the first and only anti-diabetic medication that has been approved to significantly lower the risk of sustained eGFR (estimated Glomerular Filtration Rate), cardiovascular mortality, and hospitalizations for heart failure. Both individuals with CKD and those without diabetes are eligible for this approval.

The DAPA-CKD study, whose consistent findings led to the recommendation of the indication for people with chronic kidney disease up to an eGFR greater than or equivalent to 25 ml per min per 1.73 m2, served as the foundation for the approval. To lower the risk of eGFR decline, end-stage kidney disease (ESKD), cardiovascular mortality, and heart failure, patients may continue taking their daily dose of 10 mg orally if it is above this level, which is presently not advised.

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