Schering's Betaferon approved in Europe as a first-line treatment for earliest stages of multiple sclerosis

By E. Janene Geiss

Philadelphia, June 7 - Schering AG said Wednesday that Betaferon (interferon beta-1b) has been granted marketing authorization by the European Commission for an extension of its indication to include the treatment of patients with a first clinical-event suggestive of multiple sclerosis in all 25 European member states as well as Iceland and Norway.

With this approval, Betaferon becomes the only high-dose high-frequency therapy approved for the treatment of the earliest stages of MS, according to a company news release.

The approval provides an important treatment option for patients to reduce the risk of developing clinically definite MS, and the chance to delay the progression of the disease, officials said.

The new label now allows for treatment of the majority of patients at risk for MS, those with a first clinical event that suggests onset of the disease.

"Effective treatment early in the course of the disease is important since studies have shown that irreversible nerve damage and brain atrophy can occur in the earliest stages of MS," David Bates, professor of clinical neurology at the University of Newcastle upon Tyne in the United Kingdom, said in the release.

The label extension is based on results from the Benefit study that showed that Betaferon 250 mcg treatment in the early phase of the disease reduced the risk of developing clinically definitive MS by 50% compared with a placebo.

Furthermore, patients in the Betaferon group were two times better protected than placebo-treated patients against developing MS as defined by the McDonald diagnostic criteria, officials said.

Left untreated in the placebo group, 85% of people who experienced a first clinical event went on to be diagnosed with MS within two years, officials said.

A supplemental Biologics License Application requesting an expanded label for Betaferon (marketed as Betaseron in the United States) was filed with the Food and Drug Administration by Berlex, Inc., a U.S. affiliate of Schering AG, in February and is pending review.

The Betaferon extended indication is for the treatment of patients with a single demyelinating event with an active inflammatory process, if it is severe enough to warrant treatment with intravenous corticosteroids, if alternative diagnoses have been excluded, and if they are determined to be at high risk of developing clinically definite multiple sclerosis.

The results of the study were used to define the high risk criteria for identifying patients appropriate for Betaferon treatment. The criteria reflect the differences in disease dissemination among patients with monofocal and multifocal onset of disease with a first clinical event suggestive of MS.

Schering is a Berlin research-based pharmaceutical company.

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