Sanofi's Lemtrada Gets CRL - Analyst Blog

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Sanofi ( SNY ) 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.

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 disability.

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.

Our Take

The CRL for Lemtrada is a huge disappointment for Sanofi. The company plans to appeal the FDA's decision. It is a setback for Bayer ( BAYRY ) 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. markets.

Sanofi carries a Zacks Rank #3 (Hold). Some better-ranked stocks include Forest Laboratories Inc. ( FRX ) and Jazz Pharmaceuticals ( JAZZ ). Both carry a Zacks Rank #1 (Strong Buy).



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



This article appears in: Investing , Business , Stocks

Referenced Stocks: BAYRY , CRL , FRX , JAZZ , SNY

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