Sanofi and its subsidiary Genzyme are seeking approval from Europe and the US for its multiple sclerosis drug Lemtrada (alemtuzumab).
The companies have submitted a biologics license application to the Food and Drug Administration and a marketing authorisation application to the European Medicines Agency for the drug, which showed superior results to Merck’s Rebif in two Phase 3 studies.
In the first trial, two annual cycles of alemtuzumab treatment resulted in a 55% reduction in relapse rate compared to Rebif.
The results of a second trial, presented at the American Academy of Neurology meeting in May, showed that some patients with pre-existing disability treated with Lemtrada were more than twice as likely to experience a sustained reduction in disability over two years than patients treated with Merck’s drug.
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 multiple sclerosis."
The regulatory submissions for Lemtrada include two-year controlled efficacy and safety data from both treatment-naïve 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 3 programme and included infusion-associated reactions and infections, which were generally mild to moderate in severity, according to Sanofi.
Image: Sanofi’s Strasbourg Research Center. Photo courtesy of: Antonin Borgeaud / Interlinks Image.