Committee for Medicinal Products for Human Use Adopts Positive Opinion on Novo Nordisk A/S' NovoEight
Novo Nordisk A/S announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion on its recombinant factor VIII product turoctocog alfa, with the intended brand name NovoEight. The Committee recommended marketing authorization for NovoEight for the treatment and prophylaxis of bleeding in patients with haemophilia A. NovoEight is a recombinant coagulation factor VIII, and based on advanced protein and purification technology, NovoEight has been designed for reliability, safety and portability for people with haemophilia A. Novo Nordisk expects to receive the final marketing authorization from the European Commission within the coming months. Following the Commission’s approval, Novo Nordisk expects to launch NovoEight in Europe early 2014. NovoEight has also been filed for marketing authorization in the United States, Japan, Australia and Switzerland.
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