Genzyme, a Sanofi company, has received a refuse to file letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis (MS).
FDA after consultations with the Genzyme has asked it to modify the data sets presentation to enable the agency to process the application.
The FDA has not requested additional data or further studies, according to Genzyme.
Genzyme over the coming weeks will work with the FDA to resubmit the application at the earliest time possible.
Genzyme president and CEO David Meeker said, "We have had constructive dialogue with the FDA, and we are very confident in our ability to address the agency's request and resubmit rapidly."
The company's marketing authorization application submitted to the European Medicines Agency has been accepted and the review process is underway.
Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare.
Lemtrada is the proprietary name submitted to health authorities for Alemtuzumab, which is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells.
