Genzyme Resubmits sBLA for MS Treatment Lemtrada
Sanofi arm Genzyme said Friday that the FDA will review the company’s resubmission of its supplemental Biologics License Application (sBLA) seeking approval of the multiple sclerosis treatment Lemtrada.
Genzyme said a six-month review period has been assigned for the Lemtrada sBLA, and it expects FDA action on the sBLA in the fourth quarter of this year.
The company said it resubmitted the sBLA in early May following positive discussions with the agency. The resubmission uses the same clinical study data from the original sBLA, while providing additional analyses and information to specifically address issues noted by the FDA in its Dec. 27, Complete Response Letter, the company said.
A Complete Response Letter informs companies that an application is not ready for approval.
In that letter, the FDA said Genzyme had not provided evidence from “adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects.” The FDA said that one or more additional Phase III trials of different design and execution are needed prior to Lemtrada’s approval.
At the time, Genzyme said it planned to appeal the FDA’s decision. It did not, and instead of conducting new clinical trials the company will attempt to gain approval using supplemental information to the original trials.
Lemtrada is approved in the European Union, Canada, and Australia, the company said. — Kellen Owings
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