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Sanofi and Genzyme apply for approval of MS therapy Lemtrada
Sanofi and Genzyme have applied for European and US approval of their drug Lemtrada as a treatment for relapsing multiple sclerosis (MS).
A supplemental biologics licence application pertaining to the treatment has been submitted to the US Food and Drug Administration, as well as a European Medicines Agency marketing authorisation application.
These submissions are supported by positive data from phase III clinical trials, showing the superior performance offered by the drug in comparison to another leading therapy.
Lemtrada has been developed in collaboration between Genzyme and Bayer HealthCare as a new option for the large population of people living with active MS.
Dr David Meeker, president and chief executive officer at Genzyme, said: "We believe that Lemtrada, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with MS."
This comes after Sanofi and Genzyme recently reported positive clinical data from a placebo-controlled trial of their once-daily oral MS treatment Aubagio.
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