Bagsværd, Denmark, 16 October 2013 – Today, Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics License Application (BLA) for recombinant coagulation factor VIII, Novoeight.
The FDA approved Novoeight for use in adults and children with hemophilia A for:
- Control and prevention of bleeding
- Perioperative management
- Routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
turoctocog alfa (NN7008)
Novo Nordisk recently announced the company has submitted the regulatory application to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for its turoctocog alfa (NN7008) for prevention and treatment of bleeding in people with hemophilia A.
The decision for submission was based on results from the guardian trials consisting of over 200 people with hemophilia A, making guardian the largest pre-registration clinical trial program for hemophilia A. The trials contained previously treated adults and children with severe hemophilia A.
Turoctocog alfa is a third-generation recombinant coagulation factor VIII drug, designed to increase reliability, safety and portability for patients with hemophilia A.
“We are very excited about having reached this goal. Turoctocog alfa represents a new treatment alternative for people with hemophilia A and is one of the first important outcomes of the hemophilia research strategy we embarked upon in 2006,” Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk said in a news release.
The company said that in the next few months, it plans to submit applications for regulatory approval in other countries as well.
Hemophilia A is estimated to affect 500,000 people worldwide, and is extremely under-diagnosed in developing countries.
On 19 September 2013, the Committee for Medicinal Products for Human Use(CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product NovoEight 250, 500, 100, 1500, 2000 or 3000 IU, powder and solvent for solution for injection, intended for the treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).The applicant for this medicinal product is Novonordisk. It may request are-examination of the CHMP opinion, provided it notifies the European Medicines Agency in writing of its intention within 15 days of receipt of the opinion.
The active substance of NovoEight is turoctocog alfa, human recombinant factor VIII that enables the temporary substitution of the endogenous coagulation factor VIII in haemophilia A patients. The benefits with NovoEight are its ability to prevent and treat the bleeds in previously treated patients with severe haemophilia A. The most common side effects are increase in hepatic enzymes and injection-site reaction.
A pharmacovigilance plan for NovoEight will be implemented as part of themarketing authorisation.
The approved indication is:
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).
It is proposed that NovoEight be prescribed by physicians experienced in the treatment of haemophilia A. It is proposed that treatment should be initiated under the supervision of a doctor experienced in the treatment of haemophilia.
Detailed recommendations for the use of this product will be described in thesummary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
The CHMP, on the basis of quality, safety and efficacy data submitted, considers there to be a favourable benefit-to-risk balance for NovoEight and therefore recommends the granting of the marketing authorisation.