EU regulator supports expanded use of Merck KGaA's Rebif for patients at high risk of MS

European regulators issued a positive opinion regarding Merck KGaA's filing to expand approval of Rebif (interferon beta-1a) to include patients who are at high risk of developing multiple sclerosis (MS), the company reported Friday.

Specifically, the submission seeks clearance in patients who have experienced a single demyelinating event, which Merck noted is an early sign of the disease, and who are at high risk of converting to MS. The application is supported by results of the late-stage REFLEX study, which investigated Rebif in this patient population.

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