AstraZeneca receives CDSCO approval to import, market Andexanet Alfa in India, ET HealthWorld

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Mumbai: AstraZeneca Pharma India Ltd. on Tuesday announced that it has received approval from Central Drugs Standard Control Organisation (CDSCO) in India for the import and marketing of Andexanet Alfa.

FXa inhibitors are employed for preventing and treating thrombotic events, such as deep vein thrombosis and pulmonary embolism, as well as in patients at high risk of stroke due to atrial fibrillation. While these medications effectively prevent unwanted clot formation, they also elevate the risk of major bleeding, which can be life-threatening.

The rise in the use of FXa inhibitors highlights the necessity for a specific reversal agent to mitigate the morbidity and mortality associated with major bleeding.

Dr Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said: “AstraZeneca remains steadfast in our commitment to addressing unmet medical needs, and this approval underscores our dedication to bringing life-changing medicines to India at the earliest. “With this approval, we are working on making this medicine available for patients on FXa inhibitors who have life-threatening or uncontrolled bleeding.”

It is well-tolerated and facilitates the early restart of anticoagulation following a bleeding event. The therapy is administered through an intravenous (IV) bolus over a duration of 15–30 minutes, followed by a 2-hour infusion.

Dr Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, added: “With the increasing critical role of FXa inhibitors in managing thrombotic events and atrial fibrillation-related stroke risks, the approval of Andexanet Alfa represents a significant milestone, addressing a crucial need in the medical industry. Major bleeding occurs in approximately 4-6per cent of patients treated with oral FXa inhibitors, and Andexanet Alfa stands as the sole reversal agent authorised for individuals undergoing treatment with apixaban or rivaroxaban facing life-threatening or refractory bleeding.”

  • Published On Jan 23, 2024 at 06:13 PM IST

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