Cambridge, MA – August 27, 2012 – Genzyme has announced that it has received a "Refuse to File" letter from the U.S. 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. After collaborative consultations with the FDA, the agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the application. The FDA has not requested additional data or further studies. Genzyme will work with the FDA over the coming weeks to resubmit the application as soon as possible.
“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,” said David Meeker, President and CEO, Genzyme. 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.
Read the press release on the Genzyme website
"Déjà vu; I have been here before! This is what happened to oral cladribine. It put back the cladribine application 6 months in the US and delayed the FDA decision until after the EMA decision. I believe the negative EMA decision affected the FDA's decision. Let's hope that Alemtuzumab does not go the same way as oral cladribine."
Labels: Alemtuzumab, FDA, refuse to file