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news.Novo Nordisk has filed biologic license application (BLA) for a recombinant factor XIII compound (rFXIII) for the patients with congenital factor XIII (FXIII) deficiency.
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The Phase 3 trial evaluating the safety and efficacy of rFXIII has showed positive results when compared to a historic control group of individuals who did not receive routine FXIII infusions.
In the trial, the preventive treatment with monthly recombinant FXIII injections decreased the number of bleeding episodes requiring treatment.
Novo Nordisk Biopharmaceuticals vice president Eddie Williams said this submission marks a major milestone in the expansion of their product offerings to this patient group.
"The development of a treatment that does not depend on blood products is an important step for the hundreds of patients affected worldwide by congenital FXIII deficiency," Williams said.