India approves Sanofi's Qfitlia, a new haemophilia injection
CDSCO has approved Sanofi's Qfitlia (fitusiran) for haemophilia A and B in people aged 12 and above. What it does, the risks and the access questions.
India's drug regulator, the Central Drugs Standard Control Organisation (CDSCO), has approved Sanofi's Qfitlia (fitusiran), a preventive injection for haemophilia A and B, according to Outlook India and VoH Network. Sanofi announced the marketing authorisation on 21 October 2026, Outlook reports; Outlook's own article is dated 24 October. We are covering it now because the access and safety questions matter for patients and for India's rare-disease policy.
What was approved
Qfitlia is approved for routine prophylaxis, meaning regular treatment to prevent or reduce bleeding episodes, in people aged 12 and above with haemophilia A or B, with or without "inhibitors". Inhibitors are antibodies that some patients develop against the clotting factor they are given, which makes standard treatment stop working. Sanofi calls it the first therapy that works by lowering antithrombin for routine prophylaxis, VoH reports.
It is given as an injection under the skin. Outlook's body text says once every two months, while Sanofi India's Mahajan, quoted by VoH, says "as few as six injections a year". Those fit together; an Outlook summary line saying "twice-monthly" contradicts both, so we ignore it.
How it works, in plain English
Haemophilia is a bleeding disorder in which the blood lacks a clotting factor (factor VIII in haemophilia A, factor IX in B). Standard treatment replaces the missing factor by infusion. Qfitlia does something different. Using RNA interference, it lowers production of antithrombin, a natural protein that keeps clotting in check. With less of the brake, the blood clots more easily even though the missing factor stays missing. Outlook notes it does not correct the underlying genetic defect.
What the trials showed
The approval rests on the ATLAS phase 3 programme. Outlook cites a 2023 Lancet study in patients with inhibitors: the estimated annual bleeding rate was 1.7 with fitusiran against 18.1 with on-demand bypassing agents, a 90.8% reduction. A second study in patients without inhibitors showed significantly fewer bleeds than on-demand factor treatment, though Outlook gives no figure. VoH says only that bleed protection was clinically meaningful.
The safety trade-off
Because the drug removes a clotting brake, it can raise the risk of excessive clotting and serious thrombotic events. Outlook also flags gallbladder and liver problems. Doses are guided by antithrombin blood levels, and the US label calls for liver-function tests at the start, monthly for at least six months and after dose changes. Outlook advises checking the Indian prescribing information for the local schedule, and VoH notes that antithrombin monitoring is a new practice in India. Patients should not start, stop or change treatment without a specialist.
Access is the open question
Neither article states a price or launch date. Outlook says affordability, access and whether centres can run the monitoring are the key concerns. It quotes an ICMR estimate of about 1.5 lakh people with haemophilia in India but only about 27,000 registered with the Haemophilia Federation of India; VoH gives about 1.4 lakh and 28.9 thousand. The figures differ, so treat them as rough. Sanofi India says many treated patients are still on on-demand therapy, where treatment starts after a bleed.
Dr Mukul Aggarwal of AIIMS New Delhi called it "an excellent tool in our armamentarium" while urging monitoring. Dr Nita Radhakrishnan of PGICH Noida said fewer injections could cut the burden of intravenous infusions and possibly joint damage. Vaibhav Nehra of Haemophilia Society Delhi hopes states will adopt it quickly alongside other non-factor therapies.
What it means for patients and families
For eligible patients, it adds an option that needs fewer injections than regular factor infusions, though only a specialist can decide whether it suits them. Hospitals will need antithrombin and liver-test capacity. Government procurement decisions will shape whether it reaches patients outside private care. This is information, not medical advice.
What to watch next
Watch for the launch date and price, state and national procurement decisions, the Indian prescribing information with its monitoring schedule, and any early safety reports from Indian use.
Key takeaways
- CDSCO has approved Sanofi's Qfitlia for haemophilia A and B in people aged 12 and above, with or without inhibitors.
- It works by lowering antithrombin and is injected about every two months, or around six times a year.
- A trial in patients with inhibitors found bleeding fell 90.8% against on-demand treatment.
- Risks include excess clotting and gallbladder and liver problems, so regular monitoring is needed.
- Price, launch timing and public-sector access have not been announced.
Sources
- [Outlook India: Sanofi's Qfitlia gets India nod for bleeding prevention in haemophilia patients](https://www.outlookindia.com/healthcare-spotlight/sanofis-qfitlia-gets-india-nod-for-bleeding-prevention-in-haemophilia-patients-experts-stress-access-and-monitoring)
- [VoH Network: Sanofi's Qfitlia receives marketing authorization in India](https://vohnetwork.com/news/pharma/sanofi-s-qfitlia-fitusiran-receives-marketing-authorization-in-india)
Tags: Haemophilia CDSCO Sanofi Drug approval Rare diseases