City-based AstraZeneca Pharma India Ltd., biopharmaceutical firm, on Tuesday said it has received approval from Central Drugs Standard Control Organisation (CDSCO) for importing and marketing of Andexanet Alfa in India.
Andexanet Alfa is a novel and life-saving antidote designed to reverse the effects of anticoagulant medications in emergency situations. 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, as per a company statement.
This ground-breaking treatment would address life-threatening or refractory bleeding associated with the use of Factor Xa (FXa) inhibitors, it further said.
Sanjeev Panchal, country president and MD, AstraZeneca India, said: “With this approval, we are working to make this important medicine available for patients on FXa inhibitors who have life-threatening or uncontrolled bleeding.”
With the increasing critical role of FXa inhibitors in managing thrombotic events and atrial fibrillation-related stroke risks, the approval of Andexanet Alfa represented a significant milestone, addressing a crucial need in the medical industry, said Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India.
“Major bleeding occurs in approximately 4-6% of patients treated with oral FXa inhibitors, and Andexanet Alfa stands as the sole reversal agent authorized for individuals undergoing treatment with apixaban or rivaroxaban facing life-threatening or refractory bleeding,” he added.
This CDSCO approval underscored AstraZeneca’s commitment to advancing medical solutions that addressed critical healthcare needs, ensuring that healthcare providers in India have access to innovative treatments that can make a meaningful difference in patient outcomes, claimed the pharma company.