Novo Nordisk’s NovoEight passes first stage of Japanese approval

Danish insulin giant Novo Nordisk’s (NOV: N) recombinant factor VIII product NovoEight (turoctocog alfa) has passed the review by the Committee on Drugs of Japan's Pharmaceutical Affairs and Sanitation Council.

The drug is intended for the treatment of hemophilia A, and the remaining step in the Japanese regulatory process is an official approval from the Ministry of Health, Labor and Welfare (MHLW), the company announced this morning (November 18). The passing of the review by the drug committee is a critical milestone in the Japanese review process prior to a marketing authorization being granted by the MHLW.

Final approval expected within a few months

Novo Nordisk expects to receive marketing authorization from the MHLW within a few months. After the completion of subsequent price negotiations, the company 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, adding: "This is an important milestone towards an approval offering a new treatment alternative for people with hemophilia A in Japan."

NovoEight has been studied in the guardianT clinical program; one of the largest and most comprehensive pre-registration clinical trial programs in the field of hemophilia therapy with more than 210 severe hemophilia A patients, the company noted. 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.