Immunology

Octapharma confirmed today the European Medicines Agency (EMA) has adopted a positive opinion towards human cell line recombinant human FVIII, Nuwiq®, recommending the granting of a marketing authorisation for the medicinal product for treatment and prophylaxis of bleeding (also during and after surgery) in paediatric and adult patients with haemophilia A (congenital FVIII deficiency).

Nuwiq® is the first new generation FVIII replacement protein, derived from a human cell line awaiting marketing authorisation in Europe. Nuwiq® is produced without animal derived products, and devoid of non human epitopes thought to underlie autoimmune reaction. Inhibitor antibodies to replacement FVIII typically neutralise the beneficial effect of the protein, and represent the major challenge in today's management of haemophilia A.

"Nuwiq® demonstrates outstanding efficacy in preventing and treating bleeding in haemophilia A patients previously treated with FVIII (PTPs), and its human characteristics may underlie the absence of neutralising antibodies in this population to date. Nuwiq® may represent a leap forward in combating the single greatest problem facing newly treated haemophiliacs today", says Olaf Walter, MD, PhD, MBA, Senior Vice President of International Business Units at Octapharma.