Genzyme, a Sanofi company, has submitted a supplemental biologics license application (sBLA) to the FDA and marketing authorization application (MAA) to EMA for Lemtrada to treat relapsing multiple sclerosis (RMS).
In collaboration with Bayer HealthCare, Genzyme is developing lemtrada in MS.
Genzyme President and CEO David Meeker said, "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."
Two-year controlled efficacy and safety data from both treatment-naive patients and those who relapsed while on therapy, with greater than five years of safety follow-up, were included in the regulatory submissions for Lemtrada.
Infusion-associated reactions and infections, which were generally mild to moderate in severity, were the common adverse events associated with alemtuzumab.
Autoimmune adverse events were observed in some patients with cases being detected early through a monitoring program and managed using conventional therapies.
