U.K. Cost Agency Seeks More Lemtrada Data From Sanofi (France)

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The U.K.’s health-cost regulator asked Sanofi (SAN) for more information on its multiple-sclerosis drug Lemtrada, less than a month after U.S. regulatory advisers said the drug’s trials weren’t adequate to assess its efficacy. The National Institute for Health and Care Excellence is seeking clarifications on the evidence Paris-based Sanofi’s Genzyme unit submitted on the drug, NICE said in draft guidance today. Sanofi has until Jan. 9 to submit the extra information, the institute said. NICE, which advises the U.K.’s National Health Service on which treatments provide value for money, didn’t specify what information it requested. Lemtrada, approved in the European Union in September, was a key part of Sanofi’s $20 billion acquisition of Genzyme in 2011.

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