Genzyme hit with FDA setback for MS Drug, Lemtrada

In a setback for Genzyme Corp.’s emerging multiple sclerosis franchise, the U.S. Food and Drug Administration will require the company to re-submit its approval application for the experimental therapy Lemtrada.

The news was announced Monday by Genzyme’s parent company, Sanofi (NYSE: SNY). Genzyme submitted the drug candidate for FDA review in June.

Lemtrada was previously approved as Campath for the treatment of leukemia, but Sanofi announced last week it would no longer sell the drug for that indication in anticipation of potentially selling the therapy at a higher price, once approved to treat multiple sclerosis.

Lemtrada was a major negotiating point for Cambridge, Mass-based Genzyme prior to last year’s acquisition deal with Sanofi. Lemtrada’s market potential led Sanofi to offer conditional payments to Genzyme shareholders, a clause that could increase the value of the $20.1 billion deal.

The so-called “Refuse to File” letter Genzyme received from the U.S. Food and Drug Administration will require the company to re-submit the application for approval, but will not require addition clinical trials, the company 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 CEO David Meeker said in a statement.

Genzyme said its Lemtrada application for approval in the European Union has been accepted and the review process is underway.

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