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FDA approves gene therapy for hemophilia B, now world’s costliest medicine

The Food and Drug Administration has approved a gene therapy treatment for adults with hemophilia B that costs $3.5 million per dose, making it the world’s most expensive medicine.

“Today’s approval provides a new treatment option for patients with hemophilia B and represents important progress,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Tuesday in an announcement.

Biopharmaceutical firm CSL Behring manufactures the gene therapy treatment Hemgenix, which allows patients with hemophilia to produce a protein that makes their blood clot in open wounds and halt prolonged bleeding.

Each dose of Hemgenix costs $3.