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The US Food and Drug Administration (FDA) approved Sanofi's hemophilia therapy on Friday. This paves the way for a treatment method for patients with rare blood clotting disorders. The therapy, which is marketed under the name Qfitlia, is new to the spectrum. However, Novo Nordsik and Pfizer are also active in this market.
Qfitlia is a therapy that is administered under the skin. It is intended to help prevent bleeding and reduce antithrombin levels. Qfitlia is approved for haemophilia patients aged 12 and over. According to estimates by the National Hemophilia Foundation, there are 30,000 to 33,000 haemophilia patients in the USA and around one million people worldwide are affected by the disease.
According to Reuters, the newly approved therapy is the first in its class to lower antithrombin levels and is suitable for people with haemophilia A or B with or without inhibitors.
Compared to the already approved therapies from Novo Nordisk and Pfizer, the Sanofi therapy has to be administered much less frequently, which makes treatment easier. Specifically, Qfitlia will only need to be administered every two months, while treatments with Pfizer's Hympavzi injection need to be administered weekly and Novo Nordisk's Alhemo even daily.
"Today's approval of Qfitlia is a significant step forward for hemophilia patients, as the therapy needs to be administered less frequently than other existing options," said FDA member Tanya Wroblewski as part of the approval decision.
