Sanofi drug fails to win USFDA back­ing

The Financial Express - - INTERNATIONAL -

Sanofi failed to win US reg­u­la­tory ap­proval for its mul­ti­ple scle­ro­sis drug Lem­trada, dent­ing the com­pany’s am­bi­tions of cap­tur­ing a larger share of the $20 bil­lion mar­ket for the disease. The US Food and Drug Ad­min­is­tra­tion said Sanofi’s Gen­zyme unit didn’t sub­mit ev­i­dence from “ad­e­quate and well-con­trolled stud­ies” show­ing that the ben­e­fits of Lem­trada out­weigh its side ef­fects, the Paris-based com­pany said in a state­ment on Mon­day. Sanofi dis­agrees with the con­clu­sion and plans to ap­peal, the com­pany said. Lem­trada, which was ap­proved in the Euro­pean Union in Septem­ber, and in Aus­tralia and Canada this month, was a key part of Sanofi’s $20.1bil­lion ac­qui­si­tion of Gen­zyme in 2011.

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