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FDA Approves Revolutionary (and Expensive) Hemophilia A Drug

On February 22, 2023, the FDA approved a new drug therapy, Altuviiio, for the treatment of Hemophilia A. Hemophilia A is a condition that affects approximately 1 in 5,000 male births each year.

What is Hemophilia?

Hemophilia is an extremely rare genetic condition that prevents blood from clotting properly, leading to multiple serious health complications, including spontaneous bleeding.

Hemophilia is divided into type A and type B, with A occurring four times more often than B. Altuviiio is indicated for both adults and children and can be used for perioperative management, the treatment of routine prophylaxis, and control of spontaneous bleeding episodes.

It is the first hemophilia A treatment that delivers near to near-normal factor activity levels and significantly reduces bleeds compared to previous prophylactic therapies. Altuviiio is administered in a once-weekly dose with a half-life that’s three to four times greater than other Hemophilia A medications.

Expected Cost of Altuviiio

Sanofi and Sobi manufacturers are co-developing Altuviiio, which is expected to be commercially available in April 2023.

Presently, there is little pricing information available for Altuviiio. The manufacturers stated that pricing will be “at parity” to the annual cost of prophylaxis treatment using Eloctate, which is now available at $12 per unit.

This works out to a weekly cost of $12,000 for a patient requiring 1,000 IUs, or an annual cost of $625,000. Some patients may require dosing as high as 3,000 IUs weekly, which would result in an annual cost of $1.8 million. Analysts project that the drug’s sales will reach over $1.3 billion by 2029.

For additional insights into the pharmaceutical market and drug pricing, check out this blog: PBMs Explained – What Are They and How Do They Relate to Soaring Pharma Costs?