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).

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

SANOFI-AVENTIS (SNY): Free Stock Analysis Report

ANI PHARMACEUT (ANIP): Free Stock Analysis Report

BAYER A G -ADR (BAYRY): Free Stock Analysis Report

ALLERGAN INC (AGN): Free Stock Analysis Report

To read this article on click here.

Zacks Investment Research

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

In This Story


Other Topics


Latest Markets Videos


    Zacks is the leading investment research firm focusing on stock research, analysis and recommendations. In 1978, our founder discovered the power of earnings estimate revisions to enable profitable investment decisions. Today, that discovery is still the heart of the Zacks Rank. A wealth of resources for individual investors is available at

    Learn More