NovoEight® passed the review by the Committee on Drugs of Pharmaceutical Affairs in Japan

Today, Novo Nordisk announced that NovoEight® (turoctocog alfa) has passed the review by the Committee on Drugs of Japan’s Pharmaceutical Affairs and Sanitation Council. The remaining step in the regulatory process is an official approval from the Ministry of Health, Labour and Welfare (MHLW).

The Committee on Drugs serves as an advisory body to the MHLW, in matters related to pharmaceuticals including new drug applications. The passing of the review by the drug committee is a critical milestone in the Japanese review process prior to a marketing authorisation being granted by the MHLW.

NovoEight® is a recombinant coagulation factor VIII for the treatment of haemophilia A.

Novo Nordisk expects to receive marketing authorisation from the MHLW within a few months. After the completion of subsequent price negotiations, Novo Nordisk intends to launch NovoEight® in Japan.

“We are very pleased with the results of the review of NovoEight®,” says Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, “This is an important milestone towards an approval offering a new treatment alternative for people with haemophilia A in Japan.”

NovoEight® has been studied in the guardian™ clinical programme; one of the largest and most comprehensive pre-registration clinical trial programmes in the field of haemophilia therapy with more than 210 severe haemophilia A patients. In the completed trials, NovoEight® demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development, and all patients in the surgery trial were treated effectively.

NovoEight® has been granted marketing authorisation from the European Commission in November, and received approval from the US Food and Drug Administration in October. Applications have been submitted for regulatory approval in a number of other countries.