ASTRAZENNSEAstraZeneca Pharma India Limited· PharmaceuticalsMediumPositive
Announced Tue, 17 Mar · 15:07 IST

AstraZeneca Pharma India Limited has informed the Exchange about General Updates

Regulatory Product ApprovalBusiness Updates View source PDF

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AI summary

AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Durvalumab Solution for Infusion (brand name: Imfinzi) in India for an additional indication. The new approval covers treatment of patients with unresectable hepatocellular carcinoma (uHCC) who have not received prior systemic therapy. This paves the way for marketing of Imfinzi in India for this specified additional indication, subject to other statutory approvals. The drug is already approved and marketed in India for other indications.

Likely market impact

Positive for the company as it expands the addressable market for Imfinzi in India by adding a new cancer indication (liver cancer), potentially driving future revenue growth. However, no immediate financial impact is disclosed.