FDA OKs Turoctocog Alpha (NovoEight) for Hemophilia A

Megan Brooks

Disclosures

October 17, 2013

The US Food and Drug Administration (FDA) has approved turoctocog alpha (NovoEight, Novo Nordisk) for patients with hemophilia A, a hereditary disorder caused by a lack of the blood clotting factor VIII protein.

Turoctocog alpha is a recombinant coagulation factor VIII, which works by replacing the missing factor VIII protein through intravenous injection.

The drug is approved for use in adults and children with hemophilia A for the control and prevention of bleeding, perioperative management, and routine prophylaxis to prevent or reduce the frequency of bleeding episodes, the company says in a news release.

Turoctocog alpha has been studied in one of the largest and most comprehensive preregistration clinical trial programs in the field of hemophilia therapy, the company notes. In more than 210 patients with severe hemophilia A, the drug "demonstrated good efficacy in preventing and treating bleeds and had no confirmed inhibitor development."

The approval of NovoEight "marks an important step in offering a new alternative for people with hemophilia A," Mads Krogsgaard Thomsen, executive vice president and chief science officer at Novo Nordisk, commented in the release.

The company expects to launch turoctocog alpha with the newly introduced prefilled device called MixPro shortly after April 2015.

Globally, it is estimated that 350,000 people have hemophilia A. In the United States, hemophilia occurs in about 1 of every 5000 male births, according to the Centers for Disease Control and Prevention, and about 20,000 US males are living with the disorder.

The European Medicines Agency's Committee for Medicinal Products for Human Use recommended authorization of turoctocog alpha back in September, as reported by Medscape Medical News.

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