Sanofi Secures Indian Approval for Qfitlia in Haemophilia

Mumbai, India, October 21, 2026

Antithrombin-Lowering Therapy Introduces a New Approach

Haemophilia A and haemophilia B are inherited bleeding disorders caused by deficiencies in clotting factor VIII and factor IX, respectively. These deficiencies impair the body’s ability to form stable blood clots and can lead to prolonged or spontaneous bleeding, particularly in the joints. Repeated joint bleeds may cause chronic pain, lasting joint damage and disability. Traditional haemophilia treatments commonly replace the missing clotting factor. Fitusiran uses a different mechanism by reducing antithrombin, a naturally occurring protein that inhibits thrombin generation and limits blood clot formation. By lowering antithrombin levels, the therapy aims to rebalance the coagulation system and improve the body’s ability to form clots. Qfitlia is an RNA interference (RNAi)-based medicine that targets the production of antithrombin in the liver. Its mechanism is designed to work in people with haemophilia A and B, including those who have developed inhibitors against replacement clotting factors. This broad applicability distinguishes the treatment from approaches that rely specifically on replacing factor VIII or IX.

Phase 3 Evidence Supports Bleeding Prevention

The Indian marketing authorisation is supported by findings from the ATLAS Phase 3 clinical development programme, which evaluated fitusiran for bleeding prevention in people with haemophilia, including patients with and without inhibitors. The programme demonstrated clinically meaningful protection against bleeding, assessed using the annualised bleeding rate (ABR), a measure of the number of bleeding episodes experienced over a year. Sanofi has highlighted the potential for Qfitlia to reduce the burden of frequent treatment administration. According to the company’s announcement, the therapy may offer protection with as few as six injections per year, depending on the prescribed regimen. This could provide an alternative for eligible patients who require long-term preventive treatment. The company also emphasised the importance of individualised dosing. Qfitlia dosing is guided by measured antithrombin levels, which clinicians use to help tailor treatment and manage the balance between bleeding prevention and the risk of excessive clotting. Appropriate monitoring is therefore a central component of treatment implementation.

Indian Approval Expands Prophylactic Treatment Options

Sanofi estimates that India has approximately 140,000 people living with haemophilia, while around 28,900 registered patients were cited in the company’s announcement. The company noted that some people receiving treatment continue to rely on on-demand therapy, which addresses bleeding after it occurs rather than preventing episodes in advance. The authorisation of Qfitlia expands the range of prophylactic options available to eligible patients. Sanofi India said it intends to support awareness, education and appropriate implementation of antithrombin monitoring as healthcare professionals become familiar with this treatment approach. As with other therapies that influence blood coagulation, careful clinical supervision is important. Treatment decisions, dose adjustments and monitoring must follow the approved prescribing information and be managed by qualified healthcare professionals. The Indian approval marks a regulatory milestone for Sanofi’s rare-disease portfolio and introduces an alternative mechanism for preventing bleeding in haemophilia A and B. Its impact will depend on appropriate patient selection, access to treatment and monitoring, and implementation within specialist haemophilia care. The development highlights continuing innovation in rare-disease therapeutics and preventive treatment strategies for people living with inherited bleeding disorders.

Source: Sanofi press release