AstraZeneca Pharma receives CDSCO nod for expanded use of Fasenra in India
AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Benralizumab (brand name: Fasenra) in India for an additional medical indication.
The newly approved indication allows Fasenra to be used as an add-on treatment for adult patients suffering from relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA). This rare autoimmune condition is known to cause inflammation of blood vessels, leading to organ damage.
AstraZeneca confirmed the development in a regulatory filing to the stock exchanges on May 29, 2025, under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements.
The company stated that while the permission paves the way for marketing Fasenra in India for the newly approved indication, it remains subject to receipt of additional statutory clearances if required.
Fasenra is already approved in India for other eosinophilic conditions, and this marks an important expansion in its therapeutic scope, potentially benefiting more patients with complex immunological diseases.
'The receipt of this permission paves way for the marketing of Benralizumab 30 mg/ml Solution for Injection (Brand name: Fasenra) in India for the specified additional indication,' the company noted in the filing.
The company secretary Manasa R signed off the communication to both BSE and NSE.
Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
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