Sanofi’s Qfitlia Wins Indian Approval for Haemophilia Prevention
On 21 October, 2026, India’s CDSCO authorized Sanofi’s Qfitlia (fitusiran) for haemophilia A and B. The decision covers adults and adolescents at least 12 years old, whether or not factor VIII or IX inhibitors are present. Sanofi said ATLAS Phase 3 evidence supported the decision, and Qfitlia may be administered in as few as six injections annually.
Why it matters
The approval gives Sanofi access to India’s market for preventive haemophilia treatment and adds an option designed for both haemophilia A and B. Its less frequent dosing may support broader use of prophylaxis, although treatment requires appropriate monitoring and dosing decisions.
Key facts
- 1India’s Central Drugs Standard Control Organization granted Qfitlia marketing authorization on 21 October, 2026. bwhealthcareworld.com
- 2The approved use covers adults and adolescents aged 12 years and above with haemophilia A or B, including patients with or without factor VIII or IX inhibitors. bwhealthcareworld.com
- 3Qfitlia can require as few as six injections a year for prophylaxis, according to Sanofi India. money.rediff.com
- 4The approval was supported by results from the ATLAS Phase 3 clinical development programme. money.rediff.com
Summary written by AlphAI AI Desk from 3 of 3 sources. Not investment advice. Figures are as stated by the linked sources.