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Conquering Hemophilia: Novo Nordisk Reports Encouraging Data From Phase III Trial Of NovoEight


Danish healthcare giant Novo Nordisk A/S (ADR) (NYSE: NVO) has developed NovoEight for the treatment and prevention of bleeding in patients with haemophilia A. NovoEight, which has already been launched in 11 countries including in the U.S., is a B-domain truncated recombinant human coagulation factor VIII.

Strong Data

On Wednesday morning, Novo Nordisk reported encouraging interim results from its Phase III Hemophilia trial. Presented at the International Society on Thrombosis and Haemostasis 2015 Congress, the results showed that NovoEight provided long-term efficacy and safety in the prophylaxis and treatment of bleeds in people with severe haemophilia A.

According to the World Federation of Hemophilia, an estimated 142,000 people have been diagnosed with the disease, globally. The affected population could be even higher though as the disease is underdiagnosed in developing countries. A chronic, inherited bleeding disorder, haemophilia A primarily affects males.

People suffering from the disease tend to bleed longer than most, or bleed internally.

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Novo Nordisk’s pivotal clinical trial was one of the largest and most comprehensive clinical trial programs in haemophilia. Over 210 patients were enrolled in the trial. The patients suffered from severe forms of the disease.


Commenting on the interim results, Dr. Margareth Ozelo of the IHTC Hemocentro Unicamp University of Campinas in Sao Paulo, Brazil, said that they provide an extension to the body of evidence supporting the long-term use of NovoEight. Dr. Ozelo is the investigator of the Guardian™2 trial. According to Dr. Ozelo, people suffering from haemophilia A need treatments that are effective at preventing bleeding episodes in the long-term.

The latest data adds to more than four years of data already compiled by Novo Nordisk.

In the first quarter of 2015, Novo Nordisk’s sales of haemophilia products increased by 21 percent in Danish kroner terms and 6 percent in local currency terms. Sales of haemophilia products totalled Danish kroner 2,734 million.

The increase was driven by NovoSeven in North America and international operations, as well as the ongoing rollout of NovoEight in Japan and Europe.

Novo Nordisk shares are up 0.6 percent on Thursday morning.


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