Merck Serono’s new Rebif indication receives CHMP backing

Merck Serono has been granted a recommendation from the Committee for Medicinal Products for Human Use (CHMP) for an extension of the label for Rebif, its leading multiple sclerosis (MS) treatment.

The European Medicines Agency committee has endorsed the company's application for Rebif to be approved for use in patients who have experienced a single demyelinating event and are therefore at high risk of converting to MS.

This recommendation, which includes an update to the drug's posology profile, is based on positive data from the Reflex clinical trial and will be evaluated by the European Commission over the next three months.

Dr Annalisa Jenkins, head of Merck Serono's global drug development and medical division, said this represents an "important step" towards making Rebif available to patients with early signs of MS.

"It is part of our ongoing commitment to improving access to Rebif for patients with this devastating disease and supporting its appropriate use," she added.

Last month, the company allied with Ono Pharmaceutical on a new project to develop new therapies for MS and cancer.