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AstraZeneca Secures CDSCO Approval to Introduce Andexanet Alfa in India for Treating Critical Bleeding Linked to Novel Anticoagulants.

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AstraZeneca Secures CDSCO Approval to Introduce Andexanet Alfa in India for Treating Critical Bleeding Linked to Novel Anticoagulants.

Gurugram, 20 January 2024: AstraZeneca Pharma India Ltd., a science-led biopharmaceutical company, announced today 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.

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 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.

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 to make this important medicine available for patients on FXa inhibitors who have life-threatening or uncontrolled bleeding.

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 4-6% 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.”

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.

This CDSCO approval underscores AstraZeneca’s commitment to advancing medical solutions that address critical healthcare needs, ensuring that healthcare providers in India have access to innovative treatments that can make a meaningful difference in patient outcomes.

About AstraZeneca Pharma India Ltd:

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in four therapy areas – Oncology, Cardiovascular, Renal & Metabolism and Respiratory and Rare Diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Established in 1979, it is headquartered at Bengaluru, Karnataka and has a workforce of over 900 employees across the country committed to deliver great medicines to patients through innovative science and global excellence in development and commercialization.

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