US Food and Drug Administration announced on Friday that Sanofi, a France-based pharmaceutical and healthcare company has received approval for its Qfitlia (fitusiran) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and paediatric patients 12 years of age and older with haemophilia A or haemophilia B, with or without factor VIII or IX inhibitors (neutralising antibodies).

Qfitlia does not replace the missing clotting factor. Rather, it reduces the amount of a protein called antithrombin, leading to an increase in thrombin, an enzyme critical for blood clotting. Qfitlia is administered under the skin (subcutaneously) starting once every two months. The dose and frequency of injections are adjusted using the FDA-cleared INNOVANCE Antithrombin companion diagnostic test.

Sanofi says that Qfitlia's efficacy and safety were assessed in two multicenter, randomised clinical trials which enrolled a total of 177 adult and paediatric male patients with either haemophilia A or haemophilia B.