Genzyme multiple sclerosis drug not OK’d for U.S.

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PARIS (AP) — The U.S. Food and Drug Administration hasnotified drug maker Genzyme that its
treatment for multiple sclerosis isnot ready for approval for the American market.The Frenchpharmaceutical
company Sanofi, which is the parent of Genzyme, said in astatement Monday that the FDA said the companies
had not submittedsufficient evidence to show the benefits of Lemtrada. The drug wasapproved by the European
Medicines Agency for use in the EU earlier thisyear.The FDA began reviewing Lemtrada earlier this
year.Sanofiwants to market Lemtrada as a treatment for relapsing multiplesclerosis. It is eager to bring new
drugs to the market at a time whenit is suffering from generic competition after patents on some of
itsbest-selling drugs lapsed.Copyright 2013 The Associated Press. All rightsreserved. This material may not
be published, broadcast, rewritten orredistributed.PARIS (AP) — The U.S. Food and Drug Administration
hasnotified drug maker Genzyme that its treatment for multiple sclerosis isnot ready for approval for the
American market.The Frenchpharmaceutical company Sanofi, which is the parent of Genzyme, said in astatement
Monday that the FDA said the companies had not submittedsufficient evidence to show the benefits of
Lemtrada. The drug wasapproved by the European Medicines Agency for use in the EU earlier thisyear.The FDA
began reviewing Lemtrada earlier this year.Sanofiwants to market Lemtrada as a treatment for relapsing
multiplesclerosis. It is eager to bring new drugs to the market at a time whenit is suffering from generic
competition after patents on some of itsbest-selling drugs lapsed.Copyright 2013 The Associated Press. All
rightsreserved. This material may not be published, broadcast, rewritten orredistributed.

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