June 29, 2011 | by Merck Serono S.A.
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June 29, 2011, Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has submitted an application to the European Medicines Agency (EMA) to extend the indication of Rebif, its leading treatment for multiple sclerosis (MS). The requested label extension is for the use of Rebif in patients who have experienced a single demyelinating event, an early sign of the disease, and who are at high risk of converting to MS.
“Our application to extend the indication of Rebif is based on the REFLEX1 study, which focused on patients with early signs of multiple sclerosis,” said Dr. Bernhard Kirschbaum, Executive Vice President for Global Research and Development at Merck Serono. “We remain strongly committed to addressing the medical needs of patients with multiple sclerosis at the various stages of this devastating disease.”
Merck Serono’s submission of a type II variation to extend the indication of Rebif is supported by results of the REFLEX study, which were presented at the American Academy of Neurology (AAN) in April 2011. The REFLEX study was designed to evaluate the effect of two different doses of Rebif – the currently approved 44mcg three times a week and 44mcg once a week – versus placebo, on the “Time to conversion to McDonald MS (2005)2” in patients with a first clinical demyelinating event and having magnetic resonance imaging (MRI) brain scans consistent with early signs of MS. The study met its primary endpoint for both doses by demonstrating that Rebif significantly delayed conversion to McDonald MS (2005) in those patients.
The REFLEX study was conducted with the HSA-free3 formulation of Rebif, which is now available in all European Union countries, Australia, Canada and Switzerland, as well as a number of countries in Asia, Latin America, Africa and the Middle East. The HSA-free formulation of Rebif is currently not available in the United States.
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Source: Merck Serono S.A., Press release