Sanofi (SNY - Free Report) announced that it plans to resubmit a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for its multiple sclerosis drug, Lemtrada, in the second quarter of 2014. The company took this decision following discussions with the FDA. The company is looking to get the drug approved for relapsing forms of multiple sclerosis.
The resubmitted application will address the issues raised by the FDA, when it had issued a Complete Response Letter (CRL) for Lemtrada in December last year.
The FDA had mentioned in the CRL that there was not enough evidence from adequate and well-controlled studies that Lemtrada possesses a positive benefit-risk profile. The FDA had asked Sanofi to conduct additional studies with one or more active comparator with a different design from the ones previously conducted.
Sanofi had initially announced that it plans to appeal the FDA’s decision. However following its plans to resubmit the sBLA, the company currently does not expect to pursue the appeal.
We remind that the U.S. regulatory approval path for Lemtrada has been rocky since the start. In Aug 2012, the FDA had issued a refuse-to-file letter in relation to the marketing application for Lemtrada following which the company resubmitted its marketing application in Jan 2013.
Lemtrada is already approved in the EU, Canada, Australia and Mexico. The company reported Lemtrada sales of €2 million in the fourth quarter of 2013.
We note that Bayer (BAYRY - Free Report) has the right to co-promote Lemtrada in the U.S.
Sanofi carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Alkermes (ALKS - Free Report) and Amgen Inc. (AMGN - Free Report) , both carrying a Zacks Rank #1 (Strong Buy).