Key Highlights:
- Sanofi has received CDSCO marketing authorisation in India for Qfitlia (fitusiran), an antithrombin-lowering therapy for routine prophylaxis in adults and adolescents aged 12 years or older with haemophilia A or B, with or without factor inhibitors.
- Based on the Phase III ATLAS programme, Qfitlia demonstrated clinically meaningful bleed protection, measured by annualised bleeding rates. By lowering antithrombin levels, it rebalances coagulation rather than replacing missing clotting factors.
- Qfitlia can be administered in as few as six injections annually, with dosing guided by antithrombin monitoring. Sanofi aims to expand access to prophylactic care in India, where approximately 28,900 people are registered with haemophilia.
Implications:
Qfitlia’s Indian authorization strengthens Sanofi’s haemophilia portfolio with an antithrombin-lowering approach that offers protection for haemophilia A and B, including patients with inhibitors, through as few as six injections annually. Its dosing convenience could challenge factor replacement and other non-factor therapies, while antithrombin monitoring, safety management and affordability will shape adoption in India.
Source: Express Pharma
