Sanofi decides to take a second shot on Lemtrada app

Sanofi is walking away from any plans to appeal the FDA's emphatic rejection of the multiple sclerosis drug Lemtrada, at least for now. But rather than launching the added trial that the FDA demanded ahead of any possible approval, the company ($SNY) thinks it has a shot at answering the FDA's concerns with a new application. The new application route has to be a long shot at best. The agency already made it clear that staffers would need to see some big benefits for patients before tolerating the risk involved in taking Lemtrada. But Sanofi CEO Chris Viehbacher ruled out any long, expensive new Phase III studies, which would have put the product even further behind the much improved therapies like Tecfidera that have been making the way to the market. Sanofi's $20 billion acquisition of Genzyme has been a disappointing affair, like other buyouts in the industry. Release

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