Biogen's MS Drug On Market In 1st Half '95?

Biogen has announced that it has achieved promising results in its Phase III trial of recombinant interferon beta for active relapsing/remitting multiple sclerosis. The drug seems to have slowed the rate of progression of disability and reduced the number of exacerbations. Biogen says that on the strength of these results it is confident of the safety and efficacy of the drug and intends to file for marketing approval in the USA and Europe in the first half of 1995.

If all goes according to plan, Biogen could receive an approval to market its interferon beta product in the first half of 1996, and it is likely to be the first competitor to Schering AG's Betaseron (interferon beta) which was launched earlier this year.

The trial design was to determine that treatment with beta interferon slowed the time to progression of the disease, measured as a deterioration in the Expanded Disability Status Scale of one unit above that on entry, persisting for at least six months. Patients were predominately of the relapsing/remitting type (around 85%), although some relapsing/progressive patients were included. Full analysis of the results is continuing, and will include an assessment of safety and the effects of the drug on brain plaque load measured by magnetic resonance imaging. A total of 301 patients was included in the study, which was sponsored by the US National Institutes of Health and was conducted at five centers.