15 September 2015 - Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Nuwiq, anti-haemophilic factor (recombinant), an intravenous therapy for adults and children living with haemophilia A. The Nuwiq approval includes on-demand treatment and control of bleeding episodes; routine prophylaxis to reduce the frequency of bleeding episodes; and peri-operative management of bleeding.

Nuwiq is the first B-domain deleted recombinant Factor VIII (FVIII) derived from a human cell-line, not chemically modified or fused with another protein, designed for the treatment of patients with Haemophilia A, congenital FVIII deficiency. Haemophilia A impacts the lives of up to 16,000 individuals in the U.S. and their caregivers. Although present therapies for haemophilia A treatment exist in the U.S., significant challenges still remain, including development of inhibitors and the need for multiple infusions on a prophylactic basis. Octapharma USA is a subsidiary of global human protein products manufacturer Octapharma AG, which develops and manufactures high-purity recombinant and plasma-derived coagulation factor concentrates for patients with bleeding disorders.

“Octapharma has been committed to the bleeding disorders community for many years and its decade-long drive to find solutions for hemophilia A challenges has never wavered,” said Octapharma USA President Flemming Nielsen. “Early development strategies were integral in the development of Nuwiq and these initial goals have been realized with the FDA approval. Nuwiq has demonstrated safety and efficacy in global clinical trials and has the potential to positively impact patients’ quality of life in the years ahead. Octapharma is dedicated to providing life enhancing and saving therapies for Hemophilia A and looks forward to bringing Nuwiq to the U.S. marketplace.”

The European Commission first approved the therapy in August 2014. Nuwiq is currently approved in many countries, including the United Kingdom, Australia, Canada, Germany, Italy, Sweden and Argentina.

For more details, go to: http://www.octapharma.com/en/about/newsroom/press-releases/news-single-view.html?tx_ttnews%5Btt_news%5D=676&cHash=f43f9dcd137c0d309fadc28b1749e315