The USFDA has recently approved the expanded indication of Betaseron® (interferon beta-1b) to include patients with multiple sclerosis (MS) who have experienced a first clinical episode and have MRI features consistent with MS.
A product of Berlex, Inc. (996344), a U.S. affiliate of Schering AG, Germany (NYSE: SHR), Betaseron® is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and is the only high-dose, high-frequency interferon beta indicated for patients at the earliest stage of MS.
The new indication was based on the results of BENEFIT (BEtaseron in Newly Emerging multiple sclerosis for Initial Treatment) Study of patients with a first clinical demyelinating event and MRI features suggestive of MS.
According to Ludger Heeck, Ph.D., Vice President and General Manager, Specialized Therapeutics, Berlex:
Read the full press release.We are very happy to offer people at the earliest stages of MS the benefit of an early start with high-dose, high-frequency Betaseron and its proven, long-term safety and efficacy profile.
Betaseron is the only high- dose, high-frequency interferon beta approved in the U.S. for patients who have experienced a first clinical event suggestive of MS."
Comment Preview