Lemtrada, was turned down by the U.S. Food and Drug Administration on Dec. 27 due to disagreements over the design of the trial. The original rejection was met with a strong backlash from patients, especially since the same drug had been approved in Europe, Canada and Australia based on the same data.

Genzyme CEO David Meeker

Genzyme announced today it plans to submit its once-a-year drug, which is approved outside the U.S. for multiple sclerosis, to U.S. regulators after it was rejected in December.

The Cambridge biotech’s drug, named Lemtrada, was turned down by the U.S. Food and Drug Administration on Dec. 27 due to disagreements over the design of the trial. While the FDA does not comment on rejected drugs, Genzyme said the rejection was in part because the trials of 1,600 patients compared Lemtrada to EMD Serono’s drug, Rebif, but blinded the doctors who rated the effectiveness of the drugs rather than the patients themselves. Genzyme, a subsidiary of French drug giant Sanofi, said it did this because patients would likely be able to easily tell whether they were on Rebif, a drug which must be administered three times a week, or Lemtrada, which is given once a year.

The original rejection was met with a strong backlash from patients, especially since the same drug had been approved in Europe, Canada and Australia based on the same data. Approval of the drug was a big reason Sanofi bought Genzyme in 2011, and its U.S. approval would result in a financial boon to shareholders of the company at the time of the sale.

The company vowed to appeal the decision, but today said that “following constructive discussions” with the FDA, it plans to resubmit the application instead with additional data requested by the agency.

“In light of the planned resubmission, the company does not expect to pursue an appeal at this time,” the company said in a statement.

http://www.bostonglobe.com/business/2014/04/07/genzyme-plans-resubmit-drug-candidate-fda/EYgzQpni7iTAwoGtIlav7J/story.html

Labels: Lemtrada