In a press release, Genzyme said it had resubmitted the application “earlier this month following constructive discussions with the agency.”
Genzyme said a six-month review period has been assigned for Lemtrada and added that it expects the FDA to take action on the resubmitted application in the fourth quarter.
The potential for Lemtrada was among the reasons why French drug maker Sanofi SA acquired Genzyme in 2011 for $20.1 billion. As part of that deal, Sanofi agreed to reward former Genzyme stockholders if the drug achieved certain milestones in the US market regarding approval and sales.
But even though the drug has now been approved by regulators in the European Union, Australia, Brazil, Canada, Mexico, and Guatemala, the FDA questioned the integrity of Lemtrada’s clinical trials and cited the risk of potentially serious side effects in its December rejection.
At that time, a Genzyme executive indicated that the company might appeal the FDA ruling. But in April, the company said it would file an updated application that would specifically address issues raised by the FDA.
In its Friday release, Genzyme said it submitted an updated application earlier this month.
Genzyme scientists spent more than a decade developing Lemtrada for the treatment of multiple sclerosis, a disease that affects the central nervous system. About 1,700 patients were involved in clinical testing of the drug. More than 2.3 million people have been diagnosed with MS worldwide, including about 400,000 in the United States.