Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Berlex, a US affiliate of Schering AG, has said that the FDA has expanded the indication of Betaseron to include patients with multiple sclerosis who have experienced their first clinical episode.
Subscribe to our email newsletter
Betaseron is indicated for the treatment of relapsing forms of multiple sclerosis (MS) 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 a study of patients who have experienced a first clinical episode and have MRI features suggestive of MS. The study showed that treatment with Betaseron 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 study also showed that patients with early MS found Betaseron to be a safe and well-tolerated treatment.
“Early treatment is probably one of the keys to treatment success since accumulated neurological damage is often irreversible and much of this is not clinically apparent in these early phases. Betaseron is well-accepted and provides an effective first treatment option for people with relapsing MS and those with early signs of disease,” said Mark Freedman, professor of Neurology at the University of Ottawa.