o

EUROPEAN MEDICINES AGENCY

SCIENCE MEDICINES HEALTH

EMA/109367/2016

EMEA/H/C/000074

EPAR summary for the public

NovoSeven

eptacog alfa

This is a summary of the European public assessment report (EPAR) for NovoSeven. 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 NovoSeven.

What is NovoSeven?

NovoSeven is a powder and solvent that are made up into a solution for injection. It contains the

active substance eptacog alfa.

What is NovoSeven used for?

NovoSeven is used for the treatment and prevention of bleeding connected with surgery in the

following groups of patients:

•    patients with congenital haemophilia (a bleeding disorder present from birth) who have developed or are expected to develop 'inhibitors' (antibodies) against factor VIII or IX;

•    patients with acquired haemophilia (a disease caused by the spontaneous development of inhibitors to factor VIII);

•    patients with congenital factor VII deficiency;

•    patients with Glanzmann's thrombasthenia (a rare bleeding disorder) who cannot be treated with a transfusion of platelets (components that help the blood to clot).

The medicine can only be obtained with a prescription.

30 Churchill Place • Canary Wharf • London E14 5EU • United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact

© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.

How is NovoSeven used?

Treatment with NovoSeven should be started under the supervision of a doctor who has experience in the treatment of haemophilia or bleeding disorders. NovoSeven is given by injection into a vein.

•    In haemophilia, the dose is 90 micrograms per kilogram body weight, repeated every two to three hours until the bleeding is controlled. A higher dose may be needed in children. A single dose of 270 micrograms/kg may be used in adults with a mild or moderate bleeding episode.

•    In factor VII deficiency, the dose is 15 to 30 micrograms/kg every four to six hours until the bleeding is controlled.

•    In Glanzmann's thrombasthenia, the dose is 90 micrograms/kg every two hours, for a minimum of three doses.

Patients or carers may be able to give NovoSeven themselves after suitable training. See the package leaflet for the full dosing details in all uses.

How does NovoSeven work?

The active substance in NovoSeven, eptacog alfa (activated), is almost identical to a human protein called factor VII. Eptacog alfa works in the same way as factor VII. In the body, factor VII is involved in blood clotting. It activates another factor called factor X, which starts the clotting process. By activating factor X, NovoSeven is able to give temporary control of the bleeding disorder.

Because factor VII acts directly on factor X, independently from factors VIII and IX, NovoSeven can be used in haemophilia patients who have developed inhibitors to factor VIII or IX. NovoSeven can also be used to replace the missing factor VII in patients with factor VII deficiency.

Eptacog alfa is not extracted from human blood but is produced by a method known as 'recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce eptacog alfa.

How has NovoSeven been studied?

NovoSeven has been studied in patients with haemophilia and in patients with factor VII deficiency.

The main measure of effectiveness was the number of bleeding episodes that were controlled effectively. To find out whether the medicine could be used in the home setting, the company carried out studies in 60 patients with mild to moderate bleeding episodes. NovoSeven has also been studied in patients with Glanzmann's thrombasthenia who could not be treated with platelets.

What benefit has NovoSeven shown during the studies?

In the largest study, which included 61 haemophilia patients with inhibitors, 84% of the 57 serious bleeds and 59% of the 38 surgical bleeds were controlled effectively with NovoSeven.

In the study in which NovoSeven was given in the home setting, 90% of the bleeding episodes were controlled effectively.

In the study of Glanzmann's thrombasthenia, treatment with NovoSeven was successful in 74% of the bleeds (42 out of 57).

What is the risk associated with NovoSeven?

Side effects with NovoSeven are not common. However the following side effects are seen in between 1 and 10 patients in 1,000: venous thromboembolic events (problems caused by blood clots in the veins), rash, pruritus (itching), urticaria (hives), decreased therapeutic response (lack of effectiveness of treatment) and pyrexia (fever). For the full list of all side effects reported with NovoSeven, see the package leaflet.

NovoSeven must not be used in people who are hypersensitive (allergic) to eptacog alfa, to mouse, hamster or cow proteins, or to any of the other ingredients.

Why has NovoSeven been approved?

The CHMP decided that NovoSeven's benefits are greater than its risks for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in patients with congenital haemophilia, acquired haemophilia, congenital factor VII deficiency or Glanzmann's thrombasthenia. The Committee recommended that NovoSeven be given marketing authorisation.

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

A risk management plan has been developed to ensure that NovoSeven 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 NovoSeven, including the appropriate precautions to be followed by healthcare professionals and patients.

Other information about NovoSeven

The European Commission granted a marketing authorisation valid throughout the European Union for NovoSeven on 23 February 1996.

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

This summary was last updated in 02-2016.

NovoSeven

EMA/109367/2016

Page 3/3