Positive CHMP vote for Betaferon® label to include disability progression delay in patients with the earliest signs of MS
12/5/2007
Berlin, December 5, 2007 – The Committee for Medicinal Products for Human Use (CHMP) has recommended to include new results from the landmark BENEFIT (BEtaferon in Newly Emerging multiple sclerosis For Initial Treatment) study in the Betaferon® (interferon beta-1b) label. The BENEFIT study has demonstrated a delay in disability progression with early Betaferon® treatment.
Specifically, the BENEFIT results show that treatment with Betaferon® shortly after the first clinical multiple sclerosis (MS) event or “attack” delays the development of sustained disability progression over three years by 40 percent, when compared to delayed treatment. No other MS therapy has demonstrated this effect in this early patient population. The endorsement after scientific assessment of the CHMP’s proposal by the European Commission is due end of December 2007, and, if legally approved, will enhance the label of Betaferon®.
“We are happy to receive this CHMP recommendation. Betaferon® is the only disease modifying agent approved for the treatment of MS that has been demonstrated to delay disease progression in a very early patient population. In spite of the fact that many patients with such early MS do not show marked progression in disability, treatment with Betaferon®, when initiated early, was able to significantly slow down the progression of disability compared to later initiation of treatment," said Darlene Jody, M.D., Senior Vice President and President of Bayer HealthCare’s Specialized Therapeutics Global Business Unit. “Adding the disability data to our label will clearly differentiate Betaferon® from all other products in the market place and strengthen our position.”
Around the world, 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.
About BENEFIT
BENEFIT
is a multi-center trial, sponsored by Bayer Schering Pharma AG,
comparing Betafer
