Serono: Major milestone for Multiple Sclerosis treatment in Europe

16-Mar-2001

Worldwide, multiple sclerosis (MS) is the most common disease of the central nervous system in young adults with up to two million people affected (450'000 in Europe alone).

The European Commission has approved the highest available dose of Rebif® (44mcg 3 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 CPMP1 approval is based on the assessment of the 4-year data from the PRISMS2 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.

1-The CPMP is the committee responsible for providing scientific advice and opinions to the European Medicines Evaluation Agency (EMEA), within the framework of the European centralized approval procedure. 2- Long-term efficacy of interferon beta-1a (Rebif®) in relapsing-remitting MS: 4-year results of the PRISMS study. Presented by M Freedman at

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 aspects3 in relapsing-remitting multiple sclerosis:

Progression of disability is delayed. Patients remain longer on their current EDSS4 level, which means that they are less likely to get severely disabled and, therefore can live a better quality life. The number of relapses is significantly reduced and patients are more likely to be able to remain professionally and socially active. The severity of relapses is reduced, which means fewer hospitalizations are needed.

Rebif® is registered in 60 countries worldwide and is currently the most frequently selected treatment for newly diagnosed MS patients in the world outside the US.

https://www.chemeurope.com/en/news/1879/serono-major-milestone-for-multiple-sclerosis-treatment-in-europe.html