| Systematic (IUPAC) name | |
|---|---|
| Human interferon beta | |
| Clinical data | |
| Pregnancy cat. | FDA Class C |
| Legal status | ? |
| Routes | Sub-cutaneous or Intramuscular Injection |
| Pharmacokinetic data | |
| Half-life | 10 hrs |
| Identifiers | |
| CAS number | 145258-61-3 |
| ATC code | L03AB07 |
| DrugBank | DB00060 |
| ChEMBL | CHEMBL1201562 |
| Chemical data | |
| Formula | C908H1408N246O252S7 |
| Mol. mass | 20027.0 g/mol |
| (what is this?) (verify) |
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Interferon beta-1a (also interferon beta-1-alpha) is a drug in the interferon family used to treat multiple sclerosis (MS).[1] It is produced by mammalian cells, while Interferon beta-1b is produced in modified E. coli. Interferons have been shown to produce about a 18–38% reduction in the rate of MS relapses, and to slow the progression of disability in MS patients.[2] There is currently no cure for MS, though starting a course of interferons early may slow its progress.
Interferon beta-1a is sold under the trade names Avonex (Biogen Idec) and Rebif (Merck Serono); CinnoVex (CinnaGen) is biosimilar.
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It is believed that Interferon beta based drugs achieve their beneficial effect on MS progression via their anti-inflammatory properties. Studies have also determined that Interferon beta improves the integrity of the blood-brain barrier (BBB), which generally breaks down in MS patients, allowing increasing amounts of undesirable substances to reach the brain. This strengthening of the BBB may be a contributing factor to Interferon-Beta's beneficial effects. These studies were carried out in vitro and thus may not necessarily work the same way in people.
The most commonly reported side effects are injection site disorders, flu-like symptoms, poor results on liver function tests, and blood cell abnormalities. More serious side effects include depression, seizures, or liver problems.
The two main side effects are flu-like symptoms and injection-site reactions. The flu-like symptoms tend to happen immediately after the injection and last for about half a day.[3][4] In many patients, these symptoms diminish over time, but some patients continue to experience them over the long term. One can mitigate these symptoms by using a dose that is injected less frequently and by taking the medication before bedtime. The injection-site reactions can be mitigated by rotating injection sites or by using one of the medications that requires less frequent injections. Side effects are often onerous enough that many patients ultimately discontinue taking Interferons (or glatiramer acetate, a comparable disease-modifying therapies requiring regular injections).
While these drugs improve certain diagnostic test results they do not cure MS and many patients report no perceived improvement and serious side-effects that substantially reduce quality of life. Over time, physiological tolerance and reduced effectiveness can occur due to the development of antibodies to the drugs and side effects may persist even after discontinuation.
A one-month supply of Avonex or Rebif can cost from $1,600 to more than $3,000 USD.
Avonex was approved in the US in 1996, and in Europe in 1997, and is registered in more than 80 countries worldwide. It is the leading MS therapy in the US, with around 40% of the overall market, and in Europe, with around 30% of the overall market. It is produced by the Biogen Idec biotechnology company, originally under competition protection in the US under the Orphan Drug Act.
Avonex is sold in two formulations, a lyophilized powder requiring reconstitution and a pre-mixed liquid syringe kit; it is administered once per week via intramuscular injection.
Rebif is a disease-modifying drug (DMD) used to treat multiple sclerosis in cases of clinically isolated syndromes as well as relapsing forms of multiple sclerosis and is similar to the interferon beta protein produced by the human body. It is co-marketed by Merck Serono and Pfizer in the US under an exception to the Orphan Drug Act. It was approved in Europe in 1998 and in the US in 2002 and is registered in more than 80 countries worldwide. Rebif is administered via subcutaneous injection three times per week, and can be stored at room temperature for up to 30 days.
CinnoVex is the trade name of recombinant Interferon beta 1-a, which is manufactured as biosimilar/biogeneric in Iran. It is produced in a lyophilized form and sold with distilled water for injection. Cinnovex was developed at the Fraunhofer Institute in collaboration with CinnaGen, and is the first therapeutic protein from a Fraunhofer laboratory to be approved as biogeneric / biosimilar medicine. A more water-soluble variant is currently being investigated by the Vakzine Projekt Management (VPM) GmbH in Braunschweig, Germany.
Closely related is Interferon beta-1b, also may be indicated for Multiple Sclerosis, and with a very similar drug profile. Interferon beta-1b is marketed only by Bayer in the US as Betaseron and outside the US as Betaferon.
Extavia is a new brand of interferon beta-1b to be marketed by Novartis beginning in 2009.
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