Merck Serono’s Rebif approved for new MS applications

Merck Serono has been granted European regulatory approval for its multiple sclerosis (MS) therapy Rebif to be used in an expanded specification.

The European Commission has ratified the company's application for Rebif to be used in a thrice-weekly 44 microgram treatment regimen among patients who have experienced a single demyelinating event.

Demyelinating events are an early indicator of MS and put patients at an elevated risk of converting to the disease, with data from the clinical study known as Reflex showing the safety and efficacy of Rebif for this patient population.

The new labelling for the drug is valid in all 27 members states of the EU, effective immediately.

Dr Annalisa Jenkins, head of global drug development and medical at Merck Serono, said: "Multiple sclerosis has an initial stage when clinical manifestations are not pronounced but irreversible neurological damage is taking place."

Earlier this month, Merck Serono commenced a validation study for a new quality of life questionnaire for phenylketonuria, which it is planning to launch in 2013.