Genzyme, affiliated to French drugmaker Sanofi SA (SNY,SNYNF.PK), on Monday said it has received a Refuse to File letter from the U.S. Food and Drug Administration in response to the supplemental Biologics License Application or sBLA for approving LEMTRADA (alemtuzumab) as a treatment for relapsing multiple sclerosis.
Genzyme noted that FDA, after collaborative consultations, requested that the company modify the presentation of the data sets to enable the agency to better navigate the application. The agency has not requested additional data or further studies.
Genzyme said it will work with the FDA over the coming weeks to resubmit the application as soon as 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, a unit of Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK).
by RTT Staff Writer
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