Expanded use for Merck Serono's Rebif in EU

Merck Serono, the Switzerland-based division of Germany’s Merck KGaA (MRK: DE), says that that the European Commission has approved extension of the indication of Rebif (interferon beta-1a), a treatment for relapsing forms of multiple sclerosis (MS).

This EC approval is for the use of Rebif 44mcg three times weekly 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. This approval was based on the results of the REFLEX study, which showed the safety and efficacy of Rebif in this patient population. The new labelling for Rebif is valid immediately in all 27 member states of the European Union.

"We are delighted by the European Commission decision," said Annalisa Jenkins, head of global drug development and medical at Merck Serono, adding: "Multiple sclerosis has an initial stage when clinical manifestations are not pronounced but irreversible neurological damage is taking place. Throughout the European Union, neurologists will now be able to prescribe Rebif for patients with early signs of this devastating disease."