Sanofi and Genzyme receive US approval for Aubagio

Sanofi and Genzyme have announced that their new oral treatment for multiple sclerosis (MS) Aubagio has been approved by the US Food and Drug Administration.

The regulatory body has ratified the once-daily therapy for the treatment of patients with relapsing forms of MS, having demonstrated its safety and efficacy in the phase III trial Temso.

During this study, Aubagio was seen to deliver significant improvements across several key measures of MS disease activity, such as reducing relapses, slowing the progression of physical disability and limiting the number of brain lesions.

This approval augurs well for marketing applications for Aubagio that are currently under review by the European Medicines Agency and other regulatory bodies.

David Meeker, president and chief executive officer at Genzyme, said: "The approval of our first MS therapy represents an important milestone for Genzyme and underscores our commitment to long-term leadership and partnership in the MS community."

Earlier this year, the companies also applied for EU and US approval of another relapsing multiple sclerosis treatment, Lemtrada.