Schering AG's Betaferon gets expanded US label

German drugmaker Schering AG, which is now owned by Bayer AG, says that the US Food and Drug Administration has expanded the indication of Betaseron/Betaferon (interferon beta-1b) to include patients who have experienced a first clinical episode and have MRI features consistent with multiple sclerosis. Betaferon is indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations and is the only high-dose, high-frequency interferon beta therapy indicated for patients at the earliest stage of the disease, the firm noted.

The new indication is based on results from the two-year BENEFIT study which showed that Betaferon delayed the time to a second clinical event by one year compared to placebo. In addition to establishing efficacy in this group of patients, the trial also showed that early-stage MS patients found Betaferon to be a safe and well-tolerated the drug.