FDA APPROVES SCHERING'S BETASERON FOR EARLY STAGE MS

Berlex, a U.S. affiliate of Schering AG, announced that the FDA has expanded the indication of Betaseron (interferon beta-1b) to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have MRI features consistent with MS. Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. Betaseron is the only high dose, high frequency interferon beta indicated for patients at the earliest stage of MS.

The new indication is based on results from the BENEFIT study in patients with a first clinical demyelinating event and MRI features suggestive of MS. The two-year study showed that treatment with Betaseron delayed the time to a second clinical event by one year compared with placebo. BENEFIT is the only trial to demonstrate the efficacy of a high dose, high frequency interferon beta as an effective treatment for patients with early MS. In addition to establishing efficacy in this group of patients, the study also showed that patients with early MS found Betaseron to be a safe and well-tolerated treatment, as evidenced by the findings that 93 percent of patients completed the study.

Betaseron has more than 17 years of clinical experience, with a well-established safety profile resulting from more than 700,000 patient years of treatment. A long-term follow-up study demonstrated that Betaseron remains consistently safe, effective and well-tolerated over the long term. Results of the study show that long-term continuous use of Betaseron provided 13 years of cane-free mobility, which is, on average, six years longer than when compared with untreated patients from a natural history cohort. The study also showed that patients who continuously used Betaseron experienced a significant delay in progression to secondary progressive multiple sclerosis by 6.6 years compared with patients who were not on continuous Betaseron treatment.