Sanofi resubmits multple sclerosis drug for regulatory review
- Sanofi/Genzyme is resubmitting its supplemental Biologics License Application to FDA for Lemtrada (alemtuzumab).
- Lemtrada has been developed for the treatment of relapsing multiple sclerosis (MS). This bullet states what happened.
- Sanofi received a Complete Response Letter from FDA in December.
Sanofi’s resubmission provides additional analysis of the same clinical data included in the original application. FDA wanted more comparator clinical trial data and stated that there was insufficient phase III data analysis. Action is expected by Q4 2014.