Bayer confirms positive CHMP vote for Betaferon

Bayer Schering Pharma has confirmed that the European Committee for Medicinal Products for Human Use (CHMP) has recommended that the Betaferon label includes new results from the company’s Benefit trial.

The Benefit study showed a delay in disability progression in patients with the earliest signs of multiple sclerosis (MS) who were receiving Betaferon treatment.

Results demonstrated that treatment with Betaferon shortly after the first clinical MS event delays the development of sustained disability progression over three years by 40 per cent, when compared to delayed treatment.

Darlene Jody, senior vice-president of Bayer HealthCare’s Specialised Therapeutics Global Business Unit, welcomed the CHMP recommendation.

“Adding the disability data to our label will clearly differentiate Betaferon from all other products in the market place and strengthen our position,” she indicated.
Betaferon is approved for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations, as well as for use in patients after the first attack of MS.

Earlier this year, Bayer and Genzyme Corporation announced that MabCampath had received a positive opinion from the CHMP for its marketing authorisation to be granted.