CDSCO approves Fasenra for additional indication in India

Regulatory Product ApprovalBusiness Updates View source PDF

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AI summary

AstraZeneca Pharma India has received CDSCO approval to import and distribute Benralizumab (Fasenra) 30 mg/ml pre-filled syringe for an additional indication - treatment of Hypereosinophilic Syndrome (HES) in patients aged 12 and older. This paves the way for marketing of Fasenra in India for this specified indication, subject to other statutory approvals.

Likely market impact

Positive: expanded market for Fasenra in India with a new treatment indication; supports future revenue growth potential.