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Schering gets positive opinion on Betaferon for early use in multiple sclerosis patients
By Elaine Rigoli
Tampa, Fla., May 2 - Schering AG has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) recommending that the European Commission grant an extension of the indication for Betaferon (interferon beta-1b) to add the treatment of the first clinical event suggestive of multiple sclerosis to its existing indications.
A decision by the European Commission is expected by summer 2006.
The CHMP decision is based on the results from the international Benefit study that showed that Betaferon 250 mcg treatment in the early phase of the disease reduced the risk of developing clinically definite multiple sclerosis by 50% compared with a placebo, according to a news release.
Further, patients in the Betaferon group were two times more protected against developing multiple sclerosis as defined by the McDonald diagnostic criteria, the release said.
Schering is a research-based pharmaceutical company located in Berlin.
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