FDA Approves Octapharma’s Intravenous Therapy Nuwiq
The FDA has approved Octapharma’s Nuwiq, an intravenous therapy that treats bleeding in children and adults with hemophilia A with congenital factor VIII deficiency.
Nuwiq (recombinant antihemophilic factor) is indicated for on-demand treatment and control of bleeding episodes, perioperative management of bleeding and routine prophylaxis to reduce the frequency of bleeding episodes.
The approval is based in part on a clinical study in which overall prophylactic efficacy for spontaneous bleeds was rated as excellent or good in 92 percent of adults and 97 percent of children.
Nuwiq is approved in the UK, Australia, Canada, Germany, Italy, Sweden and Argentina. Octapharma plans to launch the drug in the U.S. by early next year.
The hemophilia market is expected to grow to $11 billion next year, according to Morningstar. Hemophilia A represents the vast majority of the hemophilia market, says S&P Capital IQ analyst Jeffrey Loo. — Jonathon Shacat