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EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/284118/2012

EMEA/H/C/000520

EPAR summary for the public

Advate

octocog alfa

This is a summary of the European public assessment report (EPAR) for Advate. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Advate.

What is Advate?

Advate is a powder and solvent that are mixed together to make a solution for injection. Advate contains the active substance octocog alfa (human coagulation factor VIII).

What is Advate used for?

Advate is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). Advate is intended for either short-term or long-term use.

The medicine can only be obtained with a prescription.

How is Advate used?

Advate should be started by a doctor who has experience in the treatment of haemophilia. It should be given where resuscitation equipment is available in case of severe allergic reaction (anaphylaxis).

Advate is given by injection into a vein at a rate of up to 10 ml per minute. The dose and frequency depend on whether Advate is used to treat or prevent bleeding. The dose is also adjusted depending on the seriousness of the condition, the extent and location of the bleeding or the type of surgery. Full details on how to calculate the doses are included in the summary of product characteristics (also part of the EPAR).

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© European Medicines Agency, 2012. Reproduction is authorised provided the source is acknowledged.

How does Advate work?

The active substance in Advate, octocog alfa, is a substance that helps the blood to clot. Patients with haemophilia A lack factor VIII, which causes blood clotting problems, such as bleeding in the joints, muscles or internal organs. Advate is used to correct the factor VIII deficiency by replacing the missing factor VIII, giving temporary control of the bleeding disorder.

The human coagulation factor VIII is not extracted from human plasma but produced by a method known as 'recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.

How has Advate been studied?

Advate is similar to another medicine approved in the European Union (EU) called Recombinate, but it is prepared differently so that there are no human- or animal-derived proteins in the medicine.

Because of this Advate has been compared with Recombinate to show that the two medicines are equivalent in one main study including 111 patients with haemophilia A.

The study went on to look at the number of bleeding episodes and rated Advate's effectiveness in stopping bleeding on a scale from 'none' to 'excellent' in 107 patients, all of whom received Advate.

Three additional studies looked at the use of the medicine in the prevention of bleeding and in surgery in patients with severe or moderately severe haemophilia A, including one study in 53 children under the age of six years.

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. Advate given at high dose has been studied to see whether it is effective in clearing antibodies against factor VIII from the blood (a process known as immune tolerance induction) so that treatment with factor VIII remains effective.

What benefit has Advate shown during the studies?

In the main study, the effectiveness of Advate in the treatment of bleeding was rated as 'excellent' or 'good' in 86% of 510 new bleeding episodes. In addition, 81% of these bleeding episodes required only a single treatment with Advate.

The additional studies confirmed Advate's effectiveness, including in children under six years of age.

The data provided on immune tolerance induction in patients with inhibitors were not considered sufficient to specifically approve the medicine for this use.

What is the risk associated with Advate?

The most common side effects with Advate (seen in between 1 to 10 patients in 100) include the development of antibodies against factor VIII, dizziness, headache and pyrexia (fever). For the full list of all side effects reported with Advate, see the package leaflet.

Advate must not be used in people who are hypersensitive (allergic) to human coagulation factor VIII, to mouse or hamster protein, or to any of the other ingredients.

Why has Advate been approved?

The CHMP decided that Advate's benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Advate

The European Commission granted a marketing authorisation valid throughout the EU for Advate on 2 March 2004.

The full EPAR for Advate 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 Advate, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

This summary was last updated in 05-2012.

Advate

EMA/284118/2012

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