Tuesday May 2 10:04 AM ET
CAMBRIDGE, Mass (Reuters) - Biogen Inc. (NasdaqNM:BGEN - news) said Tuesday that Phase III trial data showed that its Avonex drug delayed the development of multiple sclerosis in individuals at high risk for the disease.
The company said that in its large study of 383 patients, Avonex showed a "highly statistically significant" effect -- or a clear trend -- on delaying the onset of clinically definite MS in people who have experienced the recent onset of a first demyelinating event.
Demyelination is the destruction of the fatty tissue that surrounds and protects nerve fibers and facilitates the flow of nerve impulses to and from the brain. Clinically definite MS is identified by the presence of at least two demyelinating events, separated by time and location in the central nervous system.
The manuscript on the data is still under review by a peer-reviewed journal.
Biogen said it is proceeding with plans to file an application for a broadened prescribing label for Avonex with regulatory agencies worldwide.
Avonex was launched in the United States in 1996 for the treatment of
relapsing forms of MS, a chronic, disabling inflammatory disease of the
central nervous system.