PHARMA/BIOTECH UPDATE: Novo’s NovoEight closer to approval in Japan

Novo Nordisk’s hemophilia A drug NovoEight is one step closer to release in Japan after it passed a review by the country’s drug committee.

Novo, who also happens to be the world’s largest insulin producer, expects to receive marketing authorization with a few months.  All that will be left  in the regulatory process is official approval from Japan’s Ministry of Health, Labor and Welfare.

NovoEight is recombinant factor for patients with factor VIII deficiencies with the following indications in adults and children: (1) controlling and prevention of bleeding episodes, (2) perioperative management and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.