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The Food and Drug Administration has decided not to approve the Sanofi developed drug Lemtrada, which is designed for multiple sclerosis.
Lemtrada was created by the drug company to treat those with relapsing remitting multiple scleroris, according to The Guardian. The drug has already been approved for use in Europe and was going to be the centerpiece of the company's $20 billion bid to takeover Genzyme.
"Genzyme's takeover was about catching up in biologics, having a greater footprint in the United States, and also largely for Lemtrada," a Bryan Garnier & Co. analyst, Eric Le Berriguad, said. "This is unquestionably a setback, as without a U.S. market such a product doesn't have the same potential."
Bloomberg reports that the hangup with the FDA was that Sanofi failed to prove that the benefits outweigh potential side effects of Lemtrada though "adequate and well-controlled studies."
The company said it planned to appeal the ruling and President David Meeker announced in a statement that he felt the company had done enough to prove to the FDA the usefulness of the drug as the drug company was using the same evidence it had for approval in Europe.