Drug Approval | November 30, 2022
AstraZeneca’s Dapagliflozin receives CDSCO approval
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD
Dapagliflozin reduces the risk of sustained eGFR, cardiovascular deaths and hospitalization for heart failure in adults with CKD
The receipt of this permission paves way for the launch of Dapagliflozin (Forxiga) tablets of 10 mg in India for the specified additional/expanded indication, subject to the receipt of related statutory approvals
Phase III trial also demonstrated a statistically significant reduction (14%) in hospitalization for any cause, bringing potential relief for patients and reducing burden on healthcare systems
The Phase IV DREAM-CKD trial will enrol 1004 CKD patients in India, including 502 dialysis dependent, 502 dialysis independent CKD patients with anemia.
Therapy recently approved in Canada under the brand name KORSUVA
AstraZeneca and Indian Society of Nephrology aim to help clinicians and healthcare practitioners to provide holistic kidney care to their patients.
People in India are still wary of organ transplants. So, there is an urgent need of increased public awareness.
Companies finalize termination with an agreed-upon settlement fee of $55M to be paid to Akebia
Results from the DELIVER and DAPA-HF Phase III trials demonstrate Dapagliflozin’ efficacy in heart failure regardless of ejection fraction
With the approval from the Central Drugs Standard Control Organisation (CDSCO), Jardiance is now the first approved therapy to improve outcomes for the full spectrum of heart failure regardless of ejection fraction
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