Extavia 250 microgram/ml powder and solvent for solution forinjection

Extavia is a powder and solvent that are made up into a solution for injection. It contains 250 micrograms (8 million international units - MIU) per millilitre of the active substance interferon beta-1b.
This medicine is the same as Betaferon, which is already authorised in the European Union (EU). The company that makes Betaferon has agreed that its scientific data can be used for Extavia.

Extavia is used to treat adult patients who have multiple sclerosis (MS). MS is a disease of the nerves, in which inflammation destroys the protective sheath around the nerves. This is called ?demyelination?.
It is used in patients:

• who have experienced the signs of MS (?demyelination event?) for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines). It is used when the patient is considered to be at high risk of developing MS. Before using it, doctors need to exclude other causes for the symptoms.
• who have MS of the type known as ?relapsing-remitting?, when the patient has attacks (relapses) within periods with no symptoms (remissions), and with at least two relapses within the last two years.
• who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active. The medicine can only be obtained with a prescription.

Extavia treatment should be started by a doctor who has experience in the treatment of MS. The treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms (8 MIU) given every other day. Extavia is given by an injection under the skin. The patients can inject Extavia themselves, provided that they have been trained. Extavia treatment should be stopped in patients who fail to respond.

The active substance in Extavia, interferon beta-1b, belongs to the group ?interferons?. Interferons are natural substances produced by the body to help it fight against attacks such as infections caused by viruses. The exact way that Extavia works in MS is not yet known but beta-interferon seems to calm down the immune system (the body?s natural defences) and prevents the relapses of MS. Interferon beta-1b is produced by a method known as ?recombinant DNA technology?. The interferon beta-1b is made by a bacterium that has received a gene (DNA), which makes it able to produce it. The replacement interferon beta-1b acts in the same way as naturally produced interferon beta.

Extavia was studied over a two year period in 338 patients with relapsing remitting MS and able to walk unaided, where its effectiveness was compared with placebo (a dummy treatment). The main measure of effectiveness was the reduction in the number of relapses.
Extavia has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with placebo. The main measure of effectiveness was the delay to progression of disability.
The study of Extavia in patients with a single demyelinating event involved 487 patients, who received either Extavia or placebo for two years. The study measured the time it took for a patient to develop clinically defined MS.

In patients with relapsing remitting MS, Extavia was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27 relapses.
One of the two studies in patients with secondary progressive MS showed a significant delay in the time to disability progression (31% risk reduction due to Extavia) and in the time to becoming wheelchair bound (39%). In the second trial, no delay in the time to disability progression was seen. In both trials, Extavia showed a reduction in the number (30%) of clinical relapses.
In the study of patients with a single demyelinating event, Extavia was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Extavia developed MS, against 45% of those who received placebo.

Very common side effects with Extavia (seen more than 1 patients in 10) are flu-like symptoms, fever, chills and injection site reactions (inflammation and pain at the site of injection). For the full list of all side effects reported with Extavia, see the Package Leaflet.
Extavia should not be used in people who have a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the other ingredients. Extavia treatment should not be started during pregnancy. If a woman becomes pregnant while taking the medicine, she should consult her doctor. Extavia should not be used in patients who are currently suffering from severe depression and/or have thoughts of suicide. Extavia should not be used in patients who have decompensated liver disease (when the liver does not function normally).

The Committee for Medicinal Products for Human Use (CHMP) decided that Extavia?s benefits are greater than its risks for the treatment of patients with a single demyelinating event, if it is severe enough to justify treatment with intravenous corticosteroids, patients with relapsing-remitting MS and patients with secondary progressive MS with active disease. They recommended that Extavia be given marketing authorisation.