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The European Commission (EC) has approved extension of the indication of Rebif (interferon beta-1a), Merck Serono’s leading treatment for relapsing forms of multiple sclerosis (MS).
This EC approval is for the use of Rebif 44 micrograms 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.
“We are delighted by the European Commission decision,” said Dr Annalisa Jenkins, Head of Global Drug Development and Medical at Merck Serono.
“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.”
The new labelling for Rebif is valid immediately in all 27 member states of the European Union.
Merck Serono has a long-standing commitment to the therapeutic area of MS. The company continues to invest in discovering and developing treatment options in this area, including active life-cycle management initiatives for Merck Serono’s foundation therapy, Rebif.
In addition, the company continues to strengthen existing, and establish new collaborations to advance research and bring innovative solutions to patients living with MS.