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PRINCETON, N.J. — Novo Nordisk has filed for approval of a treatment for a rare genetic bleeding disorder, the Danish drug maker said Wednesday.
The company submitted to the Food and Drug Administration its application for recombinant factor XIII compound, for congenital factor XIII deficiency. Current treatments for FXIII deficiency use products derived from human blood plasma, which carries the risk of contamination.
Congenital factor XIII deficiency is considered the rarest bleeding disorder, with only 600 people diagnosed worldwide. Patients with the disease, which results from a lack of the protein clotting factor XIII, have a lifelong susceptibility to bleeding problems, including spontaneous hemorrhages in the brain.