Novo Nordisk has won EU approval for its new haemophilia drug Reflixia and is planning its first European launches in the fourth quarter.
The European Commission marketing authorisation comes one week after US regulators gave the green light to the drug, which is a long-acting Factor IX treatment for haemophilia B.
Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk, said: “We are excited about the approval of Refixia in the EU, and we consider it an important expansion of the treatment options for patients with haemophilia B.
“The strong clinical profile of Refixia provides haemophilia B patients with better protection against bleeds, even into damaged joints, and an overall improved quality of life.”
The half-life of Refixia (nonacog beta pegol or N9-GP) is around five times longer
than standard factor IX products, meaning fewer injections are needed,
Consequently Novo is hoping the new product will help defend its franchise from rival long-acting haemophilia B drug Alprolix (eftrenonacog alfa) from Biogen and Swedish Orphan Biovitrum which was approved in the EU last year.