Extavia (interferon beta 1b) is a subcutaneous therapy approved by the U.S. Food and Drug Administration (FDA) to reduce the number of exacerbations in patients with relapsing-remitting multiple sclerosis (RRMS). It is also prescribed for people with a single clinical episode related to multiple sclerosis (MS), consistent with MRI results.
How Extavia works
Novartis Pharmaceuticals’ Extavia was approved by the FDA in 2009 (and in Europe in 2008). Its mechanism of action has yet to be defined. However, researchers believe that it might be related to its effect on biological response. The therapy reduces inflammation related to the demyelination process, which is directly associated with multiple sclerosis.
Clinical trials for Extavia
A clinical trial in RRMS patients demonstrated that Extavia reduces the frequency and severity of exacerbations. Patients were randomized to receive interferon beta 1b (0.05 mg every other day or 0.25 mg every other day), or a placebo. The results showed that patients given interferon beta 1b 0.25 mg for two years had 31 percent fewer exacerbations per year. Also, 25 percent of patients on interferon beta 1b remained exacerbation-free compared to 16 percent of patients on a placebo in the study.
Another clinical trial showed that in clinically isolated syndrome (CIS, the first episode of neurologic symptoms in MS, often identified as a precursor to MS), Extavia proved effective in delaying the second exacerbation in patients. This study compared 468 patients, some of whom were given interferon beta-1b (0.25 mg every other day) and others a placebo. This study showed that 72 percent of the Extavia patients hadn’t experienced another exacerbation within two years, compared to 55 percent of placebo patients.
Next steps for Extavia
While Extavia is FDA approved for relapsing forms of MS, there are ongoing clinical trials to determine if Extavia is effective in treating physical disability progression in different types of MS. Inclusion criteria in “Physical Disability in Patients Treated With Betaferon” includes “Patients with a first demyelinating event suggestive of MS, as well as patients with remittent recurrent MS (RRMS), secondary progressive MS (SPMS) and primary progressive MS (PPMS).” Betaferon by Bayer is another interferon beta-1b product.
New forms of administration are also being studied in order to reduce the injection site problems, which are one of the most common side effects. The main goal is to improve the patient’s quality of life.
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