Sanofi's Lemtrada Accepted for FDA Review - Analyst Blog

Sanofi's SNY resubmitted supplemental Biologics License Application (sBLA) for Lemtrada (alemtuzumab) has been accepted by the U.S. Food and Drug Administration (FDA) for review. The company is looking to get Lemtrada approved for the treatment of relapsing forms of multiple sclerosis.

We remind investors that in Dec 2013, the FDA had issued a complete response letter CRL for Lemtrada mentioning that there was not enough evidence from adequate and well-controlled studies to show that Lemtrada possessed 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 resubmitted the sBLA for Lemtrada on the basis of data from the original studies as well as supplemental analyses. The company provided additional information to the FDA to specifically address and resolve the issues mentioned by the FDA in the CRL. With the FDA accepting the Lemtrada sBLA, a response should be out in the fourth quarter of 2014.

Lemtrada is already approved in the EU, Canada and Australia. Another MS drug in Sanofi's portfolio is Aubagio.

We note that Bayer (BAYRY) has an agreement with Sanofi to co-promote Lemtrada in the U.S. However, Sanofi holds worldwide rights to the development and commercialization of Lemtrada for multiple sclerosis. In the first quarter of 2014, EU sales of Lemtrada were €5 million.

Our Take

The U.S. regulatory approval path for Lemtrada has been rocky since the beginning. 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. However, this was followed by a CRL in Dec 2013.

Sanofi carries a Zacks Rank#3 (Hold). Some better-ranked stocks in the health care sector include Allergan Inc. AGN and ANI Pharmaceuticals, Inc. ANIP. All these stocks carry a Zacks Rank #1 (Strong Buy).