"In a recent two-year (96 week) Phase IIIb study, 260 patients with relapsing remitting multiple sclerosis treated with the new formulation experienced a near three-fold reduction in injection-site reactions. These results are compared with historical data for the previous formulation of Rebif (30.8% versus 85.8%)1.
"Rebif is an established first line disease modifying treatment for relapsing types of MS" said Professor Gavin Giovannoni from The Royal London Hospital. "Injection site reactions can lead to discontinuation of therapy in some patients2, the notable reduction in these reactions with Rebif New Formulation has positive implications for treatment tolerability and adherence."
Rebif has a favorable benefit-to-risk profile3 and has a proven efficacy and safety profile, which has been demonstrated consistently across numerous phase III clinical trials and clinical practice1,4-6. The new formulation has consistent efficacy compared with previous experience1. At 96 weeks, 53.3% of patients remained relapse-free and overall the expanded disability status scale (EDSS) score remained stable throughout the study1.
The New Formulation of Rebif is the first and only therapy for multiple sclerosis that is serum-free both from animal (foetal bovine serum) and human (human serum albumin) derived components in either the manufacturing process or as excipients.
The new formulation of Rebif® was approved on August 10, 2007, by the European Commission and will be phased in to replace Rebif® original formulation from 1st March 2008.