Genzyme Submits Applications to FDA and EMA for Approval of LEMTRADA™ for Multiple Sclerosis
Genzyme has announced that the company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) to the European Medicines Agency (EMA) seeking approval of LEMTRADA™ (alemtuzumab) for treatment of relapsing multiple sclerosis (RMS).
Genzyme's clinical development program for LEMTRADA included two Phase III studies in which results for LEMTRADA were superior to Rebif® (high dose subcutaneous interferon beta-1a) on clinical and imaging endpoints, including a reduction in relapse rate.
In addition, as presented last month at the American Academy of Neurology meeting, some patients with pre-existing disability treated with LEMTRADA in the CARE-MS II trial were more than twice as likely to experience a sustained reduction in disability over two years than patients treated with Rebif.
"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," said Genzyme President and CEO, David Meeker.
The regulatory submissions for LEMTRADA include 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.
Common adverse events associated with alemtuzumab were consistent across the Phase III program and included infusion-associated reactions and infections, which were generally mild to moderate in severity.
Autoimmune adverse events were observed in some patients with cases being detected early through a monitoring program and managed using conventional therapies.
In addition to LEMTRADA, Genzyme's clinical development program for relapsing multiple sclerosis includes the once-daily oral treatment, AUBAGIO™ (teriflunomide), which is currently under review by the FDA and EMA.