Genzyme, the Cambridge-based division of French drug maker Sanofi SA, said Monday that it plans to resubmit its application for a multiple sclerosis drug to the US Food and Drug Administration.
In a surprise late last year, the FDA raised issues about the drug, called Lemtrada. Even though Lemtrada had been approved by regulators in the European Union, Australia, and Canada, the FDA formally rejected Lemtrada in December. A month earlier, an FDA panel of medical advisors warned of rashes, bleeding, and even thyroid cancer as possible side effects.
At the time, Genzyme said that it planned to appeal the FDA ruling and that it was also considering steps that could include meeting with federal regulators prior to a formal appeal.
In its Monday press release, Genzyme announced that “following constructive discussions” with the FDA, it plans to resubmit its supplemental Biologics License Application seeking approval of Lemtrada for the treatment of relapsing forms of MS. The resubmitted application will provide information to specifically address issues previously raised by the FDA, Genzyme said.
“In light of the planned resubmission, the company does not expect to pursue an appeal at this time,” Genzyme said in its release.
Globally, more than 2.3 million people have been diagnosed with multiple sclerosis, including about 400,000 in the United States.
The potential of that market, and the promise of Lemtrada’s approval in the United States, was a major attraction for Sanofi, which paid $20.1 billion to acquire Genzyme in 2011.