) 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
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
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
) 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.
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
ANI Pharmaceuticals, Inc.
). All these stocks carry a Zacks Rank #1 (Strong Buy).
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SANOFI-AVENTIS (SNY): Free Stock Analysis
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