EU approval for Octapharma's Nuwiq across all age groups in hemophilia A

The European Commission has approved independent Swiss biotech firm Octapharma's Nuwiq (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with hemophilia A (congenital factor VIII [FVIII] deficiency).

Nuwiq is the newest generation of FVIII replacement, produced in a human cell line cultured without additives of human or animal origin, the company stated. Nuwiq is devoid of antigenic non-human protein epitopes and has a high affinity for the von Willebrand coagulation factor, both of which are potentially important properties in reducing FVIII inhibitor formation. The development of Nuwiq aimed to address the challenges of inhibitor formation as well as the frequent infusions required for prophylaxis of bleeding.

"Nuwiq represents a potential leap forward in dealing with the greatest clinical challenges in hemophilia A, FVIII inhibitors and the frequent infusions needed for bleeding prophylaxis. In clinical trials, Nuwiq demonstrated outstanding efficacy in preventing and treating bleeding in patients previously on FVIII (PTPs). No inhibitors in clinical trials in PTPs have been seen," says Olaf Walter, senior vice president of international business units.