Mumbai: AstraZeneca Pharma India Ltd. has officially secured approval from the Central Drugs Standard Control Organisation (CDSCO) in India to import and market Andexanet Alfa, a vital reversal agent for Factor Xa (FXa) inhibitors.
FXa inhibitors play a crucial role in preventing thrombotic events, such as deep vein thrombosis and pulmonary embolism, as well as reducing stroke risk in atrial fibrillation patients. However, the use of these medications can be life-threatening due to an increased risk of major bleeding.
Dr Sanjeev Panchal, Country President and Managing Director at AstraZeneca India, said, “With this approval, we are working on making this medicine available for patients on FXa inhibitors who have life-threatening or uncontrolled bleeding.”
Andexanet Alfa serves as the only authorised reversal agent for individuals undergoing treatment with apixaban or rivaroxaban facing life-threatening or refractory bleeding, addressing a significant need in the medical industry, Dr Anil Kukreja, Vice-President of Medical Affairs and Regulatory at AstraZeneca India, informed.
He highlighted the drug’s importance in managing thrombotic events and atrial fibrillation-related stroke risks.
The therapy, administered intravenously over 15–30 minutes, followed by a 2-hour infusion, is well-tolerated and facilitates the early restart of anticoagulation following a bleeding event. Major bleeding occurs in approximately 4-6% of patients treated with oral FXa inhibitors, making Andexanet Alfa a crucial intervention in such cases.
