Schering receives positive opinion for MS drug

Schering has announced that it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the use of its drug Betaferon on patients with first-time diagnoses of multiple sclerosis (MS). The ruling should enable approval from the European Commission, the main regulatory body.

Betaferon has already been in use for almost 11 years for patients with relapsing and remitting MS, but a recent trial has found that Betaferon is also effective in the early stages of the disease. As the name implies, the drug is based on interferon beta-1a, which has been shown to reduce the rate of MS relapses by 30 to 35 per cent.

The trial, entitled Benefit, found that Betaferon reduces the risk of new patients developing full-blown, clinically definite MS by 50 per cent, if taken in the early stages of the disease. It was the first high-dosage, high-frequency study in such patients, according to Schering.

Dr Darlene Jody, MD, said: “The results from the Benefit trial show that Betaferon consistently reduced the risk of relapse when used in newly emerging MS, providing the best chance of long-term efficacy to patients with multiple sclerosis and to people who are at risk of developing MS.”

She added, “The CHMP decision represents a significant milestone, highlighting the importance of treating patients early on – even before MS is clinically definite – to provide rapid, early control of progression to clinically definite MS.”

Earlier this week, Biogen and Elan announced that their MS drug Tysabri had been accepted by the CHMP for use on patients with relapsing and remitting MS, after the drug was withdrawn following deaths resulting from the drug’s extreme side-effects.

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