GENEVA, SWITZERLAND -- February 5, 2001 -- The European Commission has approved the highest available dose of Rebif® (interferon beta-1a) - 44mcg three times per week - and recommends it as first line therapy for the treatment of patients with relapsing-remitting multiple sclerosis, the most common form of MS.
This is a milestone in the treatment of relapsing-remitting multiple sclerosis confirming the findings of the increased efficacy of a higher dose of interferon beta-1a. The CPMP approval is based on the assessment of the four-year data from the PRISMS study. The study provides clinical evidence that a high dose of interferon beta-1a, administered as early as possible in the course of the disease, significantly improves the long-term outlook for the patient.
Rebif is the only interferon beta product granted full approval by the European Commission. All previous approvals in the EU for interferon products for the treatment of MS have been subject to annual reassessment of their risk/benefit profile.
Early treatment with the highest possible dose of interferon beta-1a has been proven to significantly slow down the disease and is believed to reduce the destruction of nerve fibers (axons) in the central nervous system. The patient will have a better long-term prognosis. To maximize its benefit, interferon beta-1a needs to be administered three times per week and with the highest tolerable dose. Currently, Rebif 44mcg x 3 is the only therapy that can be given at such a high dose, whilst maintaining a good safety profile.
Rebif is currently the only MS treatment that has been recognized by the CPMP to have a significant positive impact on all major clinical aspects in relapsing-remitting multiple sclerosis: