) 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.
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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
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
) has the right to co-promote Lemtrada in the U.S.
Sanofi carries a Zacks Rank #3 (Hold). Some better-ranked stocks
), both carrying a Zacks Rank #1 (Strong Buy).