Danish pharmaceutical company Novo Nordisk has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing approval for its NovoEight (turoctocog alfa), designed for the treatment and prophylaxis of bleeding in patients with haemophilia A.
NovoEight, a recombinant coagulation factor VIII, was studied in the guardian clinical program and is based on advanced protein and purification technology.
NovoEight showed good efficacy in preventing and treating bleeds in the Phase III trials guardian 1 and guardian 3 that included previously treated adults and children with severe haemophilia A.
The product also showed no inhibitor development and all patients in the surgery trial were efficiently treated.
Novo Nordisk executive vice president and chief science officer Mads Krogsgaard Thomsen said, "We are very excited to be able to offer people with haemophilia in Europe an alternative recombinant FVIII treatment. The positive opinion for NovoEight is a significant step forward for us in our continued commitment to haemophilia."
The European Commission is anticipated to issue the final marketing approval for NovoEight in the near future and Novo Nordisk plans to introduce the product in Europe in early 2014 following the approval.
Previously, Novo Nordisk also filed for marketing approval of NovoEight in Australia, Japan, Switzerland and the US.
