FDA approves Novo Nordisk's Novoeight for hemophilia A

Company plans to launch drug in 2015 with prefilled injector

BAGSVÆRD, Denmark — The Food and Drug Administration has approved a new drug made by Novo Nordisk for treating hemophilia A, the Danish drug maker said.

Novo Nordisk announced the approval of Novoeight (turoctocog alfa), a recombinant coagulation factor VIII, for adults and children with hemophilia, a disease caused by factor VIII deficiency that results in uncontrollable bleeding.

"The approval of Novoeight marks an important step in offering a new alternative for people with hemophilia A and demonstrates our commitment to hemophilia," Novo Nordisk chief science officer and EVP Mads Krogsgaard Thomsen said.

The company plans to launch the drug in April 2015 and will launch it with a newly introduced prefilled injector called MixPro.


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