Merck Serono applies for EU Rebif label extension

Merck Serono has applied to the European Medicines Agency to expand the indication of Rebif, its widely available multiple sclerosis (MS) drug.

An application has been submitted to request that Rebif be approved as a treatment for patients who have experienced a single demyelinating event and are therefore at high risk of converting to MS.

This submission is supported by data from the clinical study Reflex, which has demonstrated the drug's efficacy in delaying the development of MS among patients in this category.

Rebif has been approved in Europe since 1998 and has been clinically proven to delay the progression of disability and lessen the risk of relapse among sufferers of the neurodegenerative illness.

Dr Bernhard Kirschbaum, executive vice-president for global research and development at Merck Serono, said: "We remain strongly committed to addressing the medical needs of patients with multiple sclerosis at the various stages of this devastating disease."

Earlier this month, the company announced the commencement of a clinical trial of Phenylketonuria treatment Kuvan, which aims to support its efficacy among infant patients.