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CAMBRIDGE, Mass. — Genzyme announced it has received a refuse-to-file letter from the Food and Drug Administration in response to the drug maker's supplemental biologics license application for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis.
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, the drug maker 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," Genzyme president and CEO David Meeker said.
Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare.