Genzyme, the Cambridge biotechnology unit of French drug maker Sanofi SA, said in a Tuesday press release that it has submitted applications to US and European regulators for Lemtrada, a drug candidate designed to treat relapsing multiple sclerosis.
Genzyme is developing Lemtrada in collaboration with Bayer HealthCare.
“There remains a large unmet treatment need for patients living with active disease and we believe that LEMTRADA, given its efficacy and unique dosing schedule, has the potential to transform the lives of patients with MS,”Genzyme president and chief executive David Meeker said in a statement.
In a late-stage clinical trial, Lemtrada improved disability scores in patients suffering from multiple sclerosis, when compared with results from an older treatment.
Genzyme pioneered a system for developing drugs that treat rare genetic disorders, such as the enzyme deficiencies Gaucher and Fabry diseases, but is now pressing forward with treatments for more common afflictions, including multiple sclerosis, an autoimmune disease that attacks the central nervous system.
One reason why Sanofi spent $20.1 billion to acquire Genzyme last year was to build up a multiple sclerosis business.
Genzyme said Tuesday that is has submitted a supplemental Biologics License Application to the US Food and Drug Administration and a marketing authorization application to the European Medicines Agency seeking approvals for Lemtrada.