FDA Rejects LEMTRADA File Letter From Genzyme

Genzyme, a Sanofi business enterprise, introduced it has acquired a Refuse to File letter from the U.S. Food and Drug Administration (FDA) to produce a supplemental Biologics License Application (sBLA) for the sanction of LEMTRADA as a remedy for relapsing multiple sclerosis.

After cooperative consultations in the FDA, the agency requested that the business enterprise modify the preview of the data sets to enable the agency to clearly navigate the solution. The Food and drug administration has never requested additional facts or further research studies. Genzyme will work in the Food and drug administration during the coming weeks to actually resubmit the solution without delay.

"Now we have had constructive information with the FDA, and we are extremely confident in our own power to address the agency's request and resubmit swiftly," said David Meeker, President and CEO, Genzyme.

The organization's marketing authorization application entered onto the European Medicines Agency is acknowledged and the review method is on-going. Genzyme is establishing LEMTRADA in MS in cooperation along with Bayer HealthCare.