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# Sanofi’s New Hemophila Drug Approved
- URL: https://www.fdaweb.com/sanofis-new-hemophila-drug-approved/
- Published: 2025-03-28T12:00:00.000Z
- Updated: 2026-09-14T14:56:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158917

FDA has approved a Sanofi NDA for Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A or B , with or without Factor VIII or IX inhibitors (neutralizing antibodies). “Qfitlia does not replace the missing clotting factor,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-novel-treatment-hemophilia-or-b-or-without-factor-inhibitors?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. “Rather, it reduces the amount of a protein called antithrombin, leading to an increase in thrombin, an enzyme critical for blood clotting.” The subcutaneous injection can be started once every two months, it says, adding that the dose and frequency of injections are adjusted using the FDA-cleared Innovance Antithrombin companion diagnostic test.

Approval is based on data from two multicenter, randomized clinical trials which enrolled a total of 177 adult and pediatric male patients with either hemophilia A or B, FDA says. The primary endpoint was the estimated annualized bleeding rate of treated bleeds. “In the participants with inhibitors who received the antithrombin-based dosing regimen of Qfitlia, there was a 73% reduction in estimated annualized bleeding rate compared to those who received on-demand treatment with bypassing agents,” it says. “In participants without inhibitors who received the antithrombin-based dosing regimen of Qfitlia, there was a 71% reduction in estimated annualized bleeding rate compared to those who received on-demand treatment with clotting factor concentrates.”

Qfitlia is required to have a Boxed Warning for thrombotic events (blood clotting) and gallbladder disease (with some patients requiring gallbladder removal), FDA says. It also has a warning about liver toxicity and the need to monitor liver blood tests at baseline and then monthly for at least six months after beginning treatment.