Novo Nordisk Reports Phase 3 Data On NovoEight In Hemophilia
By Cyndi Root
Novo Nordisk’s Phase 3 trial of NovoEight (turoctocog alfa) has shown bleeding reductions in people with hemophilia A. The company announced the results in a press release, stating that it was presenting the data at the annual meeting of the American Society of Hematology (ASH). The company states that people with the highest annualized bleeding rate (ABR) showed the largest reduction. The lead investigator of the study, Margareth Ozelo, MD, PhD, of the University of Campinas, Sao Paulo, Brazil, said, "This post hoc analysis gives an indication that patients with high baseline bleed rate can benefit from prophylaxis with NovoEight, as well as patients who maintain low ABR.”
NovoEight
The active substance in NovoEight is turoctocog alfa. The agent corrects factor VIII deficiency and replaces the missing factor VIII, controlling the bleeding disorder. Novo Nordisk makes the agent with recombinant DNA technology. The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved NovoEight for hemophilia patients to prevent bleeding in late 2013. Japan, Australia, and Switzerland approved it in 2014.
NovoEight Phase 3 Study
Novo Nordisk is reporting on a new analysis of its Phase 3 trial of NovoEight in people with hemophilia A. Over the duration of treatment, the people with the highest bleeding rates over a year experienced the greatest reductions in bleeding episodes. The Guardian 2 trial also showed that adolescents and adults treated with NovoEight achieved ABR reductions of 63 to 69 percent when compared to ABRs from the Guardian 1 trial. Novo Nordisk’s Guardian clinical program is treating 210 patients with severe hemophilia A.
Hemophilia Market
Novo Nordisk is competing in the hemophilia market against several other treatments. In October 2014, the FDA approved Baxter’s Obizur, a porcine (pig) FVIII for acquired hemophilia A. Baxter also has Rixubis [Coagulation Factor IX (Recombinant)] for pediatric and adults patients. Biogen Idec and Sobi also have therapies for hemophilia A and B, including Alprolix.
Morningstar reports that competition is steep in hemophilia, but the barriers are surmountable for new entrants. The analysis finds that the market will grow an average 5.9 percent rate to $11.4 billion in 2016. Analysts favor Bayer, Novo Nordisk, and Baxter but acknowledge Biogen Idec’s position and strength over time. Due to a “low-switch rate” wherein patients are reluctant to change therapies, Biogen Idec and new entries may have trouble penetrating the market.