Sanofi's bleeding disorder therapy "Altuviiio" gets USFDA approval


eMediNexus    24 February 2023

The French drugmaker Sanofi SA announced on Thursday that U.S. FDA officials had approved its therapy "Altuviiio" to treat a specific form of genetic bleeding illness known as hemophilia A. It anticipates launching the medication in the country in April.


With the Food and Drug Administrations approval, Sanofis factor replacement medication, "Altuviiio," will now be available in a market controlled by competitors Shire, Bayer AG, and Novo Nordisk, whose medicines have been the gold standard of care for decades.


By injecting medication into a patients vein, factor replacement therapies replenish the lost blood clotting factor so that blood can clot properly.


Before the approval, analysts predicted that Sanofis medication would rank among the best in its class. At least two analysts predicted Sanofis medicine would cost slightly more than the established factor therapies before the approval. The average yearly cost of currently available clotting factor therapy is around $300,000. 


Sanofi developed the therapy in partnership with the Swedish pharmaceutical company Sobi. Sanofi announced that "Altuviiio" would cost the same per year to treat a prophylactic patient as with Eloctate (Biogen Idecs hemophilia A medication).


The FDAs approval also gives patients a substitute for Roches market-dominating medication Hemlibra, the preferred option for this indication.


(Source:  https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-sanofis-bleeding-disorder-drug-2023-02-23/)

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