Octapharma has announced that the European Medicines Agency has recommended the approval of its new haemophilia A therapy Nuwiq.
The regulator has adopted a positive opinion on the marketing authorisation of the human cell line recombinant FVIII treatment, which is intended for the treatment and prophylaxis of bleeding in paediatric and adult patients with haemophilia, including during and after surgery.
“Octapharma has received a European regulatory recommendation for a new bleeding prevention therapy for patients with haemophilia A.“
It is the first new-generation FVIII replacement protein derived from a human cell line awaiting marketing authorisation in Europe and has demonstrated its effectiveness in the prevention and treatment of bleeding and haemostatic efficacy for surgical procedures in three pivotal trials.
Data for Nuwiq has also been submitted to regulatory authorities in Canada and Australia, with further worldwide submissions planned.
Dr Olaf Walter, senior vice-president of international business units at Octapharma, said: "Nuwiq may represent a leap forward in combating the single greatest problem facing newly-treated haemophiliacs today."
An independent Swiss company, Octapharma employs 5,000 people worldwide and currently sells its products in more than 80 countries.See all the latest jobs in Pharmaceutical