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Novo Nordisk seeks US, EU approval for hemophilia A treatment

Novo Nordisk A/S filed a biologics license application with the US Food and Drug Administration and a marketing authorization application with the European Medicines Agency for N8-GP to treat people with hemophilia A.

Hemophilia A is caused by the genetic deficiency in clotting protein, factor VIII, resulting in increased bleeding, and usually affects males.

N8-GP is an extended half-life factor VIII, which can stay in the bloodstream for a longer duration and thus requires less frequent injections.

The submission is based on the pathfinder clinical trial program which showed that N8-GP reduced bleeding rates among adults, children as well as people undergoing surgery.