Genzyme resubmits drug to FDA

Three months after the Food and Drug Administration rejected Genzyme's key drug Lemtrada for relapsing forms of multiple sclerosis, the Cambridge-based pharmaceutical company yesterday said it plans to resubmit its application for FDA review in the second quarter, rather than appeal.

In a statement, Genzyme said the resubmission will include information to "specifically address issues previously noted by the FDA" in its Dec. 27 rejection letter.

A spokeswoman for the company declined to comment.

But in December, Genzyme and its French parent, Sanofi, said the agency had said the studies of Lemtrada were not well controlled and failed to demonstrate that the drug's benefits outweighed its risks, which include thyroid cancer and bleeding.

While an advisory committee recommended that the FDA not approve the drug for newly diagnosed MS patients, "there is a population of patients where the drug would serve a purpose — patients that weren't responding to other medications available," said Richard P. Hoffmann, a Hernando, Fla., pharmacist who served on the committee.

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