New medication offers less frequent doses to reduce bleeding episodes in patients with Hemophilia A and B.
The U.S. Food and Drug Administration has recently approved Qfitlia (fitusiran) for patients aged 12 and older with hemophilia A or B. The medication works by reducing antithrombin levels to enhance the body’s natural clotting ability, unlike traditional treatments that replace missing clotting factors. The drug is administered via subcutaneous (under the skin) injection. Clinical trials demonstrated that Qfitlia reduced annual bleeding rates by over 70 percent compared to on-demand treatments.
“Today’s approval of Qfitlia is significant for patients with hemophilia because it can be administered less frequently than other existing options,” said Deputy Director Dr. Tanya Wroblewski of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. “This new treatment option highlights our continued efforts to improve the lives of patients with hemophilia.”
The FDA granted Qfitlia Orphan Drug and Fast Track designations, expediting its approval to address an unmet medical need. The medication, developed by Sanofi, aims to improve quality of life by reducing treatment frequency.
As the Lord Leads, Pray with Us…
- For Dr. Wroblewski as she fills her roles in the FDA’s Center for Drug Evaluation and Research.
- For Commissioner Marty Makary as he oversees the Food and Drug Administration.
Sources: Food and Drug Administration
