) suffered a major setback with the U.S. Food and Drug
Administration (FDA) issued a Complete Response Letter (CRL) for
its multiple sclerosis drug, Lemtrada. The company was looking to
get the drug approved for relapsing forms of multiple sclerosis.
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The FDA mentioned in the CRL that there is not enough evidence
from adequate and well-controlled studies that Lemtrada possesses
a positive benefit-risk profile. The FDA has asked Sanofi to
conduct additional studies with one or more active comparator
with a different design from the ones previously conducted.
We remind investors that Lemtrada's phase III program comprised
two pivotal phase III studies, which were completed in 2011. In
the first study, CARE-MS I, Lemtrada met the first primary
endpoint. Results showed that treatment with two annual cycles of
Lemtrada as compared to Rebif resulted in a 55% reduction in the
relapse rate over the two-year span of the study.
In the second study, CARE-MS II, Lemtrada met both the primary
endpoints. Results showed that treatment with Lemtrada resulted
in a 49% reduction in the relapse rate compared to Rebif, over a
two-year period. Additionally, Lemtrada showed a 42%
reduction in the risk of sustained accumulation (worsening) of
Lemtrada is already approved in the EU, Canada and Australia.
However, the U.S. regulatory approval path 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.
The CRL for Lemtrada is a huge disappointment for Sanofi. The
company plans to appeal the FDA's decision. It is a setback for
) as well, as it has the right to co-promote Lemtrada in the U.S.
With the FDA requiring additional studies to be conducted, there
could be a significant delay before Lemtrada reaches the U.S.
Sanofi carries a Zacks Rank #3 (Hold). Some better-ranked stocks
Forest Laboratories Inc.
). Both carry a Zacks Rank #1 (Strong Buy).