AstraZeneca Pharma India Ltd., a science-led biopharmaceutical company, announced on Saturday that it has received approval from Central Drugs Standard Control Organisation (CDSCO) in India for the import and marketing of Andexanet Alfa.
This ground-breaking treatment addresses life-threatening or refractory bleeding associated with the use of Factor Xa (FXa) inhibitors, the company claimed.
“FXa inhibitors are increasingly 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 company stated.
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. Andexanet Alfa has demonstrated both efficacy and safety in clinical trials involving healthy subjects and patients with major life-threatening bleeding.
“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 to make this important medicine available for patients on FXa inhibitors who have life-threatening or uncontrolled bleeding,” Dr. Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said.
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.
