AstraZeneca Bags CDSCO Approval To Import and Market Andexanet Alfa

AstraZeneca Pharma India Ltd has announced that it has received approval from the Indian Standard Drugs Control Organization (CDSCO) to import and market Andexanet Alfa. FXa inhibitors are used to prevent and treat thrombotic events such as deep vein thrombosis and pulmonary embolism and in patients at high risk of stroke due to atrial fibrillation. Although these drugs are effective in preventing unwanted clot formation, they also increase the risk of severe 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, as per economic times.

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 early resumption of anticoagulant therapy after bleeding. Treatment is given as an intravenous (IV) bolus over 15 to 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."