Betaseron approved in the U.S. for earliest stages of Multiple Sclerosis
Schering AG announced that the U.S. food and Drug Administration (FDA) has expanded the indication of Betaseron (interferon beta-1b, brand name of Betaferon® in the U.S.) to include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. According to Schering, 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 (BEtaferon/BEtaseron in Newly Emerging multiple sclerosis for Initial Treatment) Study of patients with a first clinical 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 to placebo. BENEFIT is the only trial to demonstrate the efficacy of a high dose, high frequency interferon beta , Betaseron, 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% of patients completed the study.
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