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FDA Approves BLA for Hemophilia A – Altuviiio

The FDA recently approved a new antihemophilic factor (recombinant) for Hemophilia A, Altuviiio (Fc-VWFXTEN fusion protein-ehtl) from Sanofi. It was approved for prophylaxis, on-demand treatment of bleeding episodes, and perioperative bleed management.

Sanofi touts the new treatment as a significant improvement over other factors on the market due to its once-weekly dosing, near-normal factor levels with prophylaxis, and overall reduced bleed levels during episodes. By comparison, other factor products indicated for prophylaxis require dosing every two days due to shorter half-life.

Sanofi will announce Altuviiio’s price when it becomes commercially available in the spring. It commented that it will likely be comparable to Eloctate which is now available at $12 per unit or a cost of $12,000 for a patient requiring 1,000 IUs weekly or, $625,000 annually. Some patients may require dosing as high as 3,000 IUs weekly resulting in an annual upper end cost of $1.8 mm.

Sanofi did not comment on how Altuviiio will be distributed. As virtually all other factor products have launched through limited distribution it is expected that Altuviiio will similarly follow suit.

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