Merck Serono announces Rebif EU approval

Merck Serono has announced that its new formulation of Rebif (interferon beta-1a) has been granted marketing authorisation as a treatment for relapsing multiple sclerosis in the European Union.

This new formulation – which has been developed using novel methods and modern technologies – aims to offer an improved immunogenicity profile and boost injection tolerability.

Recently, the company also announced other developments to boost tolerability and convenience when using Rebif, including the use of the Rebiject II auto-injector and a titration pack to ease the start of treatment with the compound.

Rebit is a disease-modifying drug that is similar to interferon beta protein naturally produced in the human body.

The drug – which has proved an effective treatment when assessed on MRI lesion area and activity, relapse rates and disability progression – modulates the immune system to reduce inflammation and fight disease.

Roberto Gradnik, head of European operations at Merck Serono, said: “The European approval of the new formulation of Rebif is an important step in our efforts to continuously provide enhanced therapeutic solutions for patients with [multiple sclerosis].”

He added that the company is pleased to bring this improved treatment option to patients across the continent.

In January 2007, Merck Serono initiated a phase II clinical trial assessing the efficacy of orally-administered cladribine as an add-on treatment with Rebif in multiple sclerosis patients.