Sanofi's Qfitlia approval: Haemophilia Prophylaxis in India

Haemophilia prophylaxis in India has gained renewed attention following the Central Drugs Standard Control Organisation’s (CDSCO) approval of Sanofi’s Qfitlia (fitusiran), a preventive therapy for patients with haemophilia A or B aged 12 years and older.

The approval adds another treatment option for a condition where recurrent bleeding can lead to damaged joints, disability and other lasting complications.

However, the development also draws attention to a persistent challenge in Indian haemophilia care: access to regular preventive treatment.

According to a 2026 multicenter analysis on the World Bleeding Disorder Registry, only 7 percent of Indian patients with severe haemophilia in the cohort were on prophylaxis, pointing towards a wide gap between treatment needs and preventive care.

Why does India's haemophilia prophylaxis gap matter?

Haemophilia is an inherited bleeding disorder associated with deficiencies in clotting factors. Haemophilia A involves factor VIII deficiency, while haemophilia B involves factor IX deficiency.

Prophylaxis is a treatment regimen that is designed to prevent or reduce bleeding, instead of waiting to treat after it occurs. The 2026 registry analysis in haemophilia shows its importance.

The study reported that:

• Only 7 percent of Indian patients with severe haemophilia received prophylaxis, compared to 60 percent in high-income settings.
• Median annual bleeding rate amongst Indian patients was 6 episodes.
• Patients receiving prophylaxis had a median annual bleeding rate of zero, compared to 8 amongst those treated on demand.

These findings highlight the potential value of preventive care, although the observational study does not establish that every patient would achieve the same outcomes.

Also Read: How Can India Pharma Bridge the Gap Between Innovation and Access

How could Sanofi's Qfitlia change preventive treatment?

Qfitlia offers a different approach from conventional factor replacement. Its active ingredient, fitusiran, uses RNA interference to reduce antithrombin, a protein that limits blood clotting.

The therapy is intended for patients aged 12 years and older with haemophilia A or B, including those with or without inhibitors against factor VIII or IX.

Key treatment features include:

• Administration: Subcutaneous injection.
• Dosing schedule: The regimen could include as low as 6 injections annually, depending on the prescribed dosing schedule.
• Objective: Prevent or reduce bleeding episodes through routine prophylaxis.

What could limit Qfitlia access in India?

Regulatory approval is an important milestone, but it does not automatically mean widespread treatment availability. First, pricing and reimbursement will influence whether patients can sustain treatment over time.

Second, access to specialists and facilities capable of appropriate monitoring may vary across regions. Third, awareness among patients and healthcare providers will be important for identifying suitable candidates.

Sanofi’s approval therefore creates an opportunity to expand preventive treatment, while leaving important questions around commercial availability, affordability and healthcare infrastructure to be addressed.

Closing India's haemophilia prophylaxis gap will require coordinated efforts across pharmaceutical companies, healthcare providers and patient-support systems.