US FDA accepts Sanofi's filing for Lemtrada MS drug

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

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

Chris Viehbacher, CEO said, they are counting on new drugs to help boost the earnings at France’s biggest drugmaker. The investors still underestimate the company’s pipeline of experimental medicines.

The company has also 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. 

FDA in October had approved Aubagio, an oral treatment for MS. Sanofi said, more than 80% of doctors specialize in the diesease in the U.S. have prescribed the drug.

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

FDA in September also approved Aubagio, an oral treatment for MS. More than 80% of the doctors specialize in the diesease in the U.S. have prescribed the drug.

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

Sanofi is a global and diversified healthcare leader that develops, discovers and distributes therapeutic solutions focused on needs of the patients.

The company has core strengths in healthcare, with 7 growth platforms including diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and new Genzyme.