US FDA approves Sanofi's bleeding disorder therapy
(Reuters) -The U.S. Food and Drug Administration approved French drugmaker Sanofi's hemophilia therapy, paving the way for a new type of treatment for patients with the rare blood clotting disorder, the regulator said on Friday.
Sanofi's subcutaneous, or under-the-skin, therapy helps prevent bleeding and lowers antithrombin, a protein that delays blood clotting, for hemophilia patients aged 12 years and older.
It is a first-in-class, antithrombin-lowering therapy for people with hemophilia A or B, with or without inhibitors.
The hemophilia market has been dominated by factor replacement therapies for decades. However, recently, gene therapies such as CSL's Hemgenix and BioMarin Pharmaceutical's Roctavian have been approved as an alternative in the United States.
Sanofi's therapy Qfitlia is to be used once every two months, compared to other available treatments such as Pfizer's once-a-week injection Hympavzi and Novo Nordisk's once-daily Alhemo.
"Today's approval of Qfitlia is significant for patients with hemophilia because it can be administered less frequently than other existing options," said Tanya Wroblewski, deputy director of the Division of Non-Malignant Hematology in the FDA's Center for Drug Evaluation and Research.
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