Positive CHMP opinion for Novo Nordisk's NovoEight

Danish insulin giant Novo Nordisk (NOV: N) revealed this morning (September 20) that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has 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 hemophilia A. if approved, the product would join a market sector valued at around $5 billion a year. The major treatments for hemophilia A include recombinant factor VIII drugs such as NovoSeven (from Novo Nordisk), Kogenate, Advate, ReFacto, Xyntha and Feiba.

NovoEight is a recombinant coagulation factor VIII, and based on advanced protein and purification technology, and has been designed for reliability, safety and portability for people with hemophilia A.