Sanofi (SNY) received the US Food and Drug Administration approval for Qfitlia used to prevent bleeding in patients aged at least 12 with hemophilia A or B, according to a statement by the FDA Friday.
Qfitlia reduces antithrombin levels to improve blood clotting instead of replacing missing clotting factors, according to the statement.
The medicine is administered subcutaneously, initially once every two months, and the dosage is adjusted using the FDA-approved Innovance Antithrombin test, the FDA said in its statement. The fixed dose of Qfitlia is not FDA approved because it led to excessive clotting in some patients.
Qfitlia's safety and effectiveness were confirmed in two studies involving 177 male patients, comparing its use to traditional on-demand treatments, the statement added. Qfitlia reduced bleeding rates by 73% in patients with inhibitors and 71% in those without inhibitors compared to standard treatments.
Qfitlia carries serious warnings about blood clot risks, gallbladder disease, and potential liver damage, requiring regular monitoring, while the most common side effects include viral infections, cold-like symptoms, and bacterial infections, the FDA noted.
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