Sanofi Filing for Lemtrada MS Drug Accepted for Review by FDA

The U.S. Food and Drug Administration accepted Sanofi’s application for approval of the multiple sclerosis drug Lemtrada, five months after rejecting an initial filing because of the way data was formatted.

Sanofi’s Genzyme unit expects a decision by the agency in the second half of the year, the Paris-based company said in a statement today. The FDA refused to accept the first Lemtrada filing and asked that the company modify the presentation of data to allow regulators to “better navigate the application,” Sanofi said Aug. 27.

Chief Executive Officer Chris Viehbacher is counting on new drugs to help boost earnings at France’s biggest drugmaker. Investors still underestimate the company’s pipeline of experimental medicines, he said in an interview Jan. 25.

Sanofi also has applied for marketing authorization for Lemtrada in the European Union, and the European Medicines Agency is expected to rule in the second quarter, according to the statement. Sanofi, which obtained Lemtrada in the $20.1 billion purchase of Genzyme in 2011, is developing the medicine in collaboration with Bayer AG.

Sanofi rose 0.5 percent to close at 73.09 euros Jan. 25 in Paris trading. The stock has gained 2.4 percent this year.

The FDA in September approved Aubagio, an oral treatment for MS. More than 80 percent of doctors specializing in the disease in the U.S. have prescribed the drug, Sanofi said in today’s statement.

“The initial uptake of Aubagio by U.S. prescribers shows the importance of a once-daily oral option in MS,” said David Meeker, Genzyme’s president. “The acceptance of the Lemtrada file in the U.S. marks another important milestone in bringing this potentially transformative therapy to MS patients.”

Novartis AG’s Gilenya, approved in 2010, was the first pill to treat the illness, and Biogen Idec is seeking regulatory backing for the BG-12 oral medicine.

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