Now Reading: Sanofi gets CDSCO approval for Qfitlia haemophilia therapy in India
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Sanofi gets CDSCO approval for Qfitlia haemophilia therapy in India
The Story in Brief
Sanofi Healthcare has received marketing authorisation from the Central Drugs Standard Control Organisation (CDSCO) for Qfitlia (fitusiran), a therapy to prevent bleeding in haemophilia patients. The approval covers adults and adolescents aged 12 years and older, with or without factor VIII or IX inhibitors.
Qfitlia is the first antithrombin-lowering therapy designed for routine prophylaxis, requiring as few as six injections a year for both Haemophilia A and B patients. The approval is based on data from the ATLAS phase 3 clinical programme, which showed clinically meaningful bleed protection. Parwas Mahajan, Business Head, Rare Diseases at Sanofi (India), said the therapy has the potential to significantly expand access to prophylaxis in India.
Indian Opinion Analysis
The Economic Times, BusinessLine and The Pharma Letter all report the CDSCO approval as a straightforward regulatory milestone, with near-identical facts and no critical framing. The only material difference is that The Pharma Letter, a trade publication, identifies Qfitlia as the first antithrombin-lowering therapy and gives the drug controller’s full name (DCGI), while the Indian outlets foreground patient access. The uniform coverage suggests the story carries no regulatory or political controversy. The concrete next step for Sanofi will be the therapy’s commercial launch and uptake among India’s haemophilia population.
Coverage: 3 sources, 3 neutral
Sources (3): economictimes.indiatimes.com (neutral report), thehindubusinessline.com (neutral report), thepharmaletter.com (neutral report)
This brief was synthesised by AI from the 3 sources linked above, so one read covers every framing they carry. Methodology and corrections.
