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news.Schering AG has completed the enrollment of 2,100 patients for a study of Betaferon, one of its top drugs, which treats the relapsing-remitting form of multiple sclerosis. The study will examine the effects of a high dosage of the drug.
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Betaferon is already an approved and widely used treatment for relapsing-remitting multiple sclerosis (RRMS) in a 250mcg dose. However, the study now seeks to ascertain whether patients could derive even greater benefit from a 500 mcg dose of the drug.
Additionally, the study, known as “Beyond”, will compare the efficacy of Betaferon with rival drug glatiramer acetate (a non-interferon) in patients with RRMS. It will be the first head to head comparison of Betaferon with glatiramer acetate.
“The study is expected to show that the Beyond dose of Betaferon is more efficacious than any currently available interferon”, said Dr Joachim-Friedrich Kapp, head of specialized therapeutics of the Schering Group. “Our goal is to noticeably improve the outcome and prognosis for MS patients”.
Results from the first phase of the Beyond program, published in September 2003, showed that the Beyond dose of Betaferon was safe and well tolerated. The final results of the study program are expected in 2007. The study and is being conducted in more than 200 centers in 26 countries.