What is Extavia?
Extavia is a powder and solvent for solution for injection.Contains 250 micrograms (8 million international units, MIU) per milliliter of the active substance interferon beta-1b.
The medicine is similar to Betaferon, which is already authorized in the European Union (EU). The manufacturer of Betaferon considered that the scientific data relating to Betaferon could also be used for Extavia.
What is Extavia used for?
Extavia is used to treat adult patients with multiple sclerosis (MS). Multiple sclerosis is an inflammatory disease that affects the central nervous system and occurs with the destruction of the protective sheath that covers the nerve cells. This process is called "demyelination".
Extavia is indicated for the treatment of:
• patients who have experienced signs of multiple sclerosis ('demyelinating event) for the first time and whose signs are severe enough to warrant treatment with corticosteroids (anti-inflammatory medicines). The medicine is prescribed when the patient is considered to be at high risk of get multiple sclerosis Before prescribing it, your doctor must rule out other causes of your symptoms.
• patients with multiple sclerosis of the type known as "relapsing-remitting", characterized by attacks (relapses) alternating with symptom-free periods (remissions), in patients with at least two relapses in the last two years;
• patients with secondary progressive multiple sclerosis (the type of MS that occurs after relapsing-remitting multiple sclerosis), with active disease.
The medicine can only be obtained with a prescription.
How is Extavia used?
Treatment with Extavia should be started by a doctor experienced in the treatment of multiple sclerosis. It is recommended to start with 62.5 micrograms (one quarter of the dose) every other day and slowly increase the amount over 19 days to reach the recommended dose of 250 micrograms (8 MIU) given each day. Extavia is given. by subcutaneous injection (under the skin) The patient can inject the medicine himself after receiving the appropriate instructions Treatment with Extavia should be stopped if the patient does not respond to therapy.
How does Extavia work?
The active substance in Extavia, interferon beta-1b, belongs to the group of 'interferons'. Interferons are natural substances produced by the body to help it cope with attacks such as viral infections. The mechanism of action of Extavia in the treatment of multiple sclerosis is not yet known, however it appears that interferon beta is able to regulate the immune system (the body's natural defenses) and thus prevent recurrence of the disease. Interferon beta-1b is produced by a method known as "recombinant DNA technique": that is, it is obtained from a bacterium in which it is A gene (DNA) has been inserted which makes it capable of producing interferon. The analogous interferon beta-1b acts in the same way as natural interferon beta.
How has Extavia been studied?
Extavia was studied over 2 years in 338 patients with relapsing-remitting multiple sclerosis who were able to walk unassisted, comparing its efficacy to placebo (a dummy treatment). The main measure of efficacy in this study was reduction in the number of relapses.
Extavia was also tested in 1,657 patients over two studies in subjects with secondary progressive multiple sclerosis who were able to walk; in these studies the medicine was compared with placebo. The main measure of effectiveness was the delay in the progression of disability.
The study of Extavia in patients with a single demyelinating event involved 487 patients, who were treated with Extavia or placebo for two years. The study measured the time interval before the onset of the clinically defined form of multiple sclerosis.
What benefit has Extavia shown during the studies?
In patients with relapsing-remitting multiple sclerosis, Extavia was more effective than placebo in reducing the number of relapses: patients treated with the drug experienced an average of 0.84 relapses per year, those treated with placebo 1.27.
In one of the two studies carried out in patients with secondary progressive multiple sclerosis, a significant delay in the progression of disability was observed (31% risk reduction thanks to Extavia) and an extension of the time prior to the time in which the patient is forced to "use of wheelchairs (39%). In the second study, no delay in the progression of disability was observed. In both studies, Extavia found a reduction (30%) in the number of clinical relapses.
In the study involving patients with a single demyelinating event, Extavia was shown to reduce the risk of clinically defined multiple sclerosis: 28% of patients treated with Extavia developed multiple sclerosis, compared with 45% of patients treated with placebo.
What is the risk associated with Extavia?
The most common side effects seen with Extavia (affecting more than 1 in 10 patients) were: flu symptoms, fever, chills and sting site reactions (pain and inflammation). For the full list of side effects reported with Extavia, see the Package Leaflet. Extavia should not be used in patients with a history of hypersensitivity (allergy) to natural or recombinant interferon beta, human albumin or any of the others. substances that make up the drug. Treatment with Extavia should not be started during pregnancy. Patients who become pregnant during therapy should consult their doctor. In addition, Extavia should not be taken by patients with severe depression and / or with suicidal thoughts Extavia is not indicated in patients with decompensated liver disease (in whom the liver is unable to function normally).
Why has Extavia been approved?
The Committee for Medicinal Products for Human Use (CHMP) considered that the benefits of Extavia for the treatment of patients with a single demyelinating event, if this event is severe enough to require treatment with intravenous corticosteroids, to patients with relapsing-remitting multiple sclerosis patients and patients with secondary progressive multiple sclerosis with active disease. The CHMP therefore recommended the granting of the "Marketing Authorization" for Extavia.
Other information about Extavia:
On May 20, 2008, the European Commission granted Novartis Europharm Limited a "Marketing Authorization" for Extavia, valid throughout the European Union..
The full version of the EPAR for Extavia can be found here.
Last update of this summary: 4-2008
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