India Pharma Outlook Team | Friday, 30 May 2025
Highlights:-
AstraZeneca Pharma India has been given permission by the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India (CDSCO) to import and market Fasenra (Benralizumab 30 mg/ml Solution for Injection) for a further clinical indication.
Adult patients with reverting or stubborn eosinophilic granulomatosis with polyangiitis (EGPA), a compound autoimmune disease characterized by blood vessel inflammation and significantly raised eosinophil levels, may now be able to use benralizumab as an adjuvant therapy, cheers to the regulatory approval.
With this change, AstraZeneca will be able to sell Fasenra in India for the treatment of EGPA, which enhances clinical care for a large number of patients with long-term and frequently unacknowledged clinical issues. Notably, this move is cautious due to potential pending constitutional approvals.
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Eosinophils, which are essential for inflammation and tissue damage in EGPA, rapidly decrease when exposed to the monoclonal antibody Fasenra (Benralizumab), which targets the IL-5 receptor on eosinophils. Fasenra has already received marketing authorization for severe eosinophilic asthma in several countries, including India, and this new change extends its scope to other respiratory and immunologic diseases. One of India's top biopharmaceutical companies, AstraZeneca Pharma India develops, produces, distributes, and markets novel medications associated with various therapeutic classes.
Additionally, the business provides clinical trial services to affiliated foreign businesses, demonstrating its commitment to global innovation and development. By making this addition, AstraZeneca has shown its dedication to offering precise treatments to enhance the care of Indian patients.
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