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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/589429/2013

EMEA/H/C/002719

EPAR summary for the public

NovoEight

turoctocog alfa

This is a summary of the European public assessment report (EPAR) for NovoEight. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use NovoEight.

For practical information about using NovoEight, patients should read the package leaflet or contact their doctor or pharmacist.

What is NovoEight and what is it used for?

NovoEight is a medicine that contains the active substance turoctocog alfa. It is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). NovoEight is intended for either short-term or long-term use.

How is NovoEight used?

NovoEight can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of haemophilia.

NovoEight is available as a powder and solvent that are mixed together to make a solution for injection into a vein. The dose and frequency of treatment depend on whether it is used to treat or prevent bleeding, as well as the seriousness of the haemophilia, the extent and location of the bleeding and the patient's condition. For further information, see the summary of product characteristics (also part of the EPAR).

Patients or their carers may be able to administer NovoEight themselves at home once they have been trained appropriately. For full details, see the package leaflet.

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How does NovoEight work?

Patients with haemophilia A lack factor VIII, which causes blood clotting problems, such as bleeding in the joints, muscles or internal organs. The active substance in NovoEight, turoctocog alfa, works in the body in the same way as human factor VIII and helps the blood to clot. NovoEight is used to correct the factor VIII deficiency by replacing the missing factor VIII, thereby giving temporary control of the bleeding disorder.

Turoctocog alfa is made by a method known as 'recombinant DNA technology': it is made by hamster cells into which a gene (DNA) has been introduced that make them able to produce it.

What benefits of NovoEight have been shown in studies?

NovoEight has been shown to be effective at preventing and treating bleeding episodes in two main studies involving a total of 213 patients with haemophilia A. None of the studies compared NovoEight with any other medicines.

In the first study involving 150 patients aged 12 years and above, adolescents who used NovoEight for prevention of bleeding had an average of 5.55 bleedings per year whereas adults had an average of 6.68 bleedings per year. When used for the treatment of spontaneous bleeding episodes, NovoEight was rated as 'excellent' or 'good' at treating 403 of 499 of the bleeding episodes. In addition, 89.4% of the bleeding episodes resolved following 1 to 2 treatments with NovoEight.

In the second study involving 63 children less than 12 years of age, children treated with NovoEight had an average of 5.33 bleedings per year. NovoEight was rated as 'excellent' or 'good' at treating 116 of the 126 bleeding episodes. In addition, 95.2% of the bleeding episodes resolved following 1 to 2 treatments with NovoEight.

What are the risks associated with NovoEight?

The most common side effects with NovoEight (which may affect up to 1 in 10 people) are increased levels of liver enzymes and injection site reactions. Hypersensitivity (allergic) reactions have been reported rarely and may in some cases progress to severe allergic reactions. Some patients may develop factor VIII inhibitors, which are antibodies (proteins) that the body's immune system produces against factor VIII and which can cause the medicine to stop working resulting in a loss of bleeding control. In such cases, a specialised haemophilia centre should be contacted.

For the full list of all side effects reported with NovoEight, see the package leaflet.

NovoEight must not be used in patients who are known to be allergic to hamster protein. For the full list of restrictions, see the package leaflet.

Why is NovoEight approved?

The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that NovoEight's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that NovoEight has been shown to be effective at treating and preventing bleeding episodes, with effects similar to other factor VIII products. The safety profile of NovoEight was also considered similar to other factor VIII products.

What measures are being taken to ensure the safe and effective use of NovoEight?

A risk management plan has been developed to ensure that NovoEight is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for NovoEight, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about NovoEight

The European Commission granted a marketing authorisation valid throughout the European Union for NovoEight on 13 November 2013.

The full EPAR for NovoEight can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. For more information about treatment with NovoEight, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 11-2013.

NovoEight

EMA/589429/2013

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