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European regulators back wider indication for Merck Serono’s Rebif

CHMP recommends new early use indication for Merck Serono’s multiple sclerosis drug

European regulators have recommended approving an extended indication for Merck Serono's multiple sclerosis (MS) treatment Rebif (interferon beta-1a) that would allow the drug to be used at an earlier stage of the condition's development.

If accepted by the European Commission, Rebif would be authorised for the treatment of patients with a single event related to the central nervous system with an active inflammatory process, if alternative diagnoses have been excluded, and the patient is at high risk of developing MS.   

Dr Annalisa Jenkins, head of global drug development and medical at Merck Serono, said: “This is an important step towards making Rebif available across Europe to patients with early signs of multiple sclerosis. It is part of our on-going commitment to improving access to Rebif for patients with this devastating disease, and supporting its appropriate use.”

The new indication recommendation follows the results of the phase III REFLEX study that demonstrated demonstrating that Rebif significantly delayed onset of MS (probability of conversion) in patients with a first clinical event suggestive of the disease.

The study, which used a human serum albumin-free formulation of Rebif, involved 517 patients. The probability of conversion to MS over two years was 86 per cent in the placebo group, 62 per cent in patients who received Rebif 44mcg three times a week and 76 per cent in patients who received once-weekly of Rebif 44mcg.

Rebif is currently authorised to treat patients with relapsing multiple sclerosis and could soon face competition from Sanofi's Lemtrada, which may be filed for approval next year.

21st November 2011


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