Schering AG’s Betaferon approved in EU as first-line drug for MS

Schering AG has announced that Betaferon has been approved by the European Commission as a first-line treatment for multiple sclerosis (MS).

The company says that the decision makes Betaferon the only high-dose, high-frequency therapy approved for use on patients in the earliest stages of MS. Furthermore, if treated early enough, patients can reduce the risk of developing clinically-definite MS (CDMS) and reduce the development of the disease.

One study showed that patients administered with Betaferon reduced the risk of developing CDMS by 50 per cent in comparison with the placebo. Those in the placebo group left untreated went on to develop MS two years after their first episode in 85 per cent of patients.

David Bates, professor of clinical neurology at the University of Newcastle-upon-Tyne and chairman of the MS Forum, remarked: “Effective treatment early in the course of the disease is important since studies have shown that irreversible nerve damage and brain atrophy can occur in the earliest stages of MS.”

“We now have the ability to treat patients from the earliest sign of MS with therapy that has an excellent safety profile over 16 years,” he added.

Betaferon has already been in use for at least 16 years and has the “broadest experience” of any drug for the treatment of MS, according to Schering AG. It has been approved for all relapsing forms of MS and is known to be safe and tolerated well after 16 years of studying the behaviour of patients using the drug.

According to the UK’s Multiple Sclerosis Society, approximate 2,500,000 patients suffer from MS throughout the world, including 85,000 Britons. The prognosis of the disease varies from person to person – it may relatively mild, episodic or severely disabling, according to the charity.

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