Home » Drug Information » FDA-Approved Drugs » 1995
Medical Areas: Neurology
View By: Year Company Therapeutic Areas Drug Names
Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Biogen IDEC
Approval Status: Recommended for Approval in December 1995
Treatment Area: multiple sclerosis
Avonex is used for treatment of relapsing forms of multiple
sclerosis. It is the first drug to have proven, in a blinded
clinical trial, that it slows the progression of disability as well
as reduces the frequency of exacerbations.
In a phase III clinical trial, 40% fewer subjects on Avonex
progressed one or more units on the Expanded Disability Status
Scale than patients on placebo. The EDSS is the standard measure of
disease progression in multiple sclerosis. In addition, subjects
receiving Avonex in the trial experienced 32% fewer exacerbations
of the disease than subjects on placebo. Furthermore, MRI studies
showed a statistically significant reduction in the number and
volume of active lesions in treated patients compared to placebo
patients.
The side effects observed in the trial were modest and largely
involved flu-like symptoms characteristic of all interferon drugs.
There were minimal injection-site reactions.