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Msg  40782 of 56240  at  11/10/2013 12:30:00 AM  by


 In response to msg 40764 by  mdcelts
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Re: Genzyme, Lemtrade, and FDA problems

wow, that description of the briefing documents is about as ugly as you can get. This was the drug Ssnofi and GENZ couldn't agree on value on for the takeover so they have that CVR trading to compensate former GENZ shareholders if it's as big as it was supposed to be. those comments sound really horrible. The drug is approved in Europe but given there are so many other MS drugs around now this sounds headed for FDA rejection:

"The future of a key multiple sclerosis drug developed by Cambridge biotech Genzyme was put in doubt Friday after federal regulators suggested it could be too dangerous to approve because of what they believe are the treatment’s limited benefits.

The drug, Lemtrada, was pivotal to sealing French drug maker Sanofi SA’s $20.1 billion purchase of Genzyme Corp. in 2011. Sanofi is counting on it and other new treatments to rejuvenate the global drug giant’s sales.

Until Friday, approval from the Food and Drug Administration seemed likely, especially since European regulators in September signed off on the sale of Lemtrada overseas. But an FDA staff report — prepared in advance of a Wednesday advisory panel meeting to consider whether to recommend Lemtrada’s sale in the United States — indicates Genzyme now faces a major hurdle.

The report said the drug has “serious and potentially fatal safety issues,” including a risk of cancer. While such staff reviews are not binding, advisory panels — made up of prominent medical specialists — give them significant consideration.

“That’s like a death sentence,” Fabian Wenner, an analyst with Kepler Cheuvreaux in Zurich, said of the report. “It isn’t what everyone expected, an issue with safety. It seems to be a more fundamental issue here.”

"In the report on Genzyme’s Lemtrada, FDA drug reviewer John Marler detailed a litany of conditions and complications that could be caused by the MS treatment. He also called into question the way clinical trials of the drug were conducted.

“The certainty of the risks of potentially lifelong hypothyroidism [a thyroid condition], serious infusion reactions, melanoma, and other malignancies, Grave’s ophthalmopathy [a thyroid-related eye disease] and other autoimmune disorders and prolonged increased susceptibility to infection may not be balanced by the uncertainty that exists in the limited evidence of potential clinical benefits from clinical trials that were not well-controlled,” Marler wrote.

Specifically, the FDA questioned why Sanofi did not try to keep patients in trials from knowing whether they were taking the medicine, suggesting that may have skewed results.

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Msg # Subject Author Recs Date Posted
40783 Re: Genzyme, Lemtrade, and FDA problems jetmanbash 0 11/10/2013 2:04:36 AM

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