Novo Nordisk files long-acting factor IX for haemophilia B in US


Novo Nordisk has filed its long-acting factor IX, nonacog beta pegol in the US for haemophilia B.

Nonacog beta pegol is a glycopegylated recombinant factor IX with a longer half-life, developed for patients with haemophilia B. Novo said that the drug's half-life is five times longer than standard factor IX products, meaning fewer injections are needed.

Although Novo has long had a presence in haemophilia, it faces competition in both haemophilia A and B. In haemophilia B, Biogen and Swedish Orphan Biovitrum have Alprolix (coagulation factor IX (recombinant)) approved in the EU and the US.

The filing of nonacog beta pegol is based on the results from the PARADIGM clinical trial programme which involved 115 patients with severe or moderately severe haemophilia B. Nonacog beta pegol was found to be efficacious in routine prophylaxis, treatment of bleeding episodes and surgery for adults, adolescents and children.

Nonacog beta pegol appeared to be well-tolerated and no safety concerns were identified.

In phase 3 trials, once-weekly administration of 40 IU/kg nonacog beta pegol maintained factor IX activity levels above 15%, reduced the median annualised bleeding rate to 1.0 and showed a potential to prevent bleeds in target joints. These patients reported a significant improvement in quality of life during the trial.

Novo Nordisk has also filed the treatment in the EU.

Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, said: "With its high factor activity level, less frequent dosing and reduced bleeding rate, nonacog beta pegol has the potential to improve the quality of life for both patients and their families."

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17 May, 2016