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 Betaferon® treatment initiated after a first clinical event with delayed treatment. The study is being conducted at 98 sites in 20 countries and includes 468 patients presenting with a first clinical episode suggestive of MS and typical MRI findings.
The primary outcome measures are time to diagnosis of CDMS (clinically definite MS), time to confirmed disability progression (measured by EDSS, Expanded Disability Status Scale) and patient-reported Quality of Life outcomes (FAMS-TOI). At the beginning of the study, patients were randomized to receive either 250 micrograms of interferon beta-1b (Betaferon®) every other day or placebo as a subcutaneous injection in a double-blind fashion.
The placebo-controlled treatment period lasted up to 24 months or up to the time when patients experienced a second event and were diagnosed with clinically definite MS. All study participants were then invited to participate in a follow-up study with Betaferon® to prospectively assess the impact of such early versus delayed treatment with Betaferon® on the long-term course of the disease for a total observation time of five years.
In the placebo-controlled phase, Betaferon® delayed the progression from the first clinical event to clinically definite multiple sclerosis (CDMS) in a statistically significant and clinically meaningful manner, corresponding to a risk reduction of 47% (hazard ratio = 0.53, 95% confidence interval (0.39, 0.73), p