CHMP Backs New Hemophilia A Drug NovoEight

Marcia Frellick

Disclosures

September 20, 2013

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended authorization for the hemophilia A drug turoctocog alpha (NovoEight, NovoNordisk) yesterday for the treatment and prophylaxis of bleeding in patients with hemophilia A, a hereditary disorder caused by a lack of the blood clotting factor VIII protein.

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

The CHMP evaluated data from 2 phase 3 trials involving more than 210 previously treated adults and children with severe hemophilia, according to a NovoNordisk news release.

In a summary announcing the approval, CHMP said the drug's benefits include its ability to prevent and treat the bleeds in previously treated patients with severe hemophilia A. The most common adverse effects are an increase in hepatic enzymes and reaction at the injection site.

The company said it expects to receive final marketing authorization from the European Commission within months. With this approval, the company plans to launch NovoEight in Europe in early 2014.

The company said it is also seeking market authorization in the United States, Japan, Australia, and Switzerland.

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. Hemophilia A is about 4 times as common as hemophilia B.

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