US FDA clears NovoNordisk

The US Food and Drug Administration has approved a new indication for Danish drugmaker NovoNorisk's NovoSeven coagulation factor VIIa (recombinant), making it the first and only recombinant therapy approved for the treatment of acquired hemophilia, a rare and potentially fatal bleeding disorder. As a recombinant therapy, NovoSeven is not plasma-derived and poses no risk of human viral transmission through its use. The Agency approved the Danish biotechnology firm's NovoSeven for the treatment of bleeding episodes in patients with acquired hemophilia, and in the prevention of bleeding in surgical interventions or invasive procedures in patients with acquired hemophilia.