Interferon beta-1a

Interferon beta-1a

Clinical data
Pregnancy category	FDA Class C
Routes of administration	Sub-cutaneous or Intramuscular Injection
ATC code	L03AB07 (WHO)
Pharmacokinetic data
Elimination half-life	10 hrs
Identifiers
IUPAC name Human interferon beta
CAS Number	145258-61-3
DrugBank	BTD00093
Chemical and physical data
Formula	C908H1408N246O252S7
Molar mass	20027.0 g/mol g·mol−1

Interferon beta-1a is a drug in the interferon family used to treat multiple sclerosis (MS). It is produced by mammalian cells while Interferon beta-1b is produced in modified E. coli. Interferons have been shown to have about a 18-38% reduction in the rate of MS relapses, and to slow the progression of disability in MS patients . None of the products on the market is a cure, but patients today who start early on Interferons may beneficially alter the natural course of the disease.

There are two principal competitors in the market for this drug and one biogeneric / biosimilar one:

• Avonex (Biogen Idec)
• Rebif (EMD Serono)
• CinnoVex (CinnaGen)

Overview

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 (outside a living organism; a "petri dish" experiment), so it does not necessarily mean it works the same in people.

Nonetheless, Interferons have side effects. The two main ones 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. 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).

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.

While these drugs improve certain diagnostic test results they do not cure MS and many patients report no perceived improvement but 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 anywhere from $1,600 to more than $2,000 USD.

Avonex

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

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 EMD 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

Main article: CinnoVex

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.

Related drugs

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 Berlex in the US as Betaseron and outside the US as Betaferon by Schering AG.

Extavia is a new brand of interferon beta-1b to be marketed by Novartis beginning in 2009.

See also

• Interferon beta-1b