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U.S. FDA Temporarily Stops Zafgen Biopharmaceutical’s Obesity Drug Trials

by Vishnuprasad on October 17, 2015 at 2:26 PM
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U.S. FDA Temporarily Stops Zafgen Biopharmaceutical’s  Obesity Drug Trials

Zafgen, a biopharmaceutical company dedicated to developing novel obesity therapeutics, announced that the U.S. Food and Drug Administration (FDA) has put a partial hold on the development of its obesity treatment.

According to the drug regular, the 22-year-old patient who died during a late-stage study had been taking the drug.

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The company's stock plunged 35% to $13.52 in early trading last Friday. The company also said the decision of the regulator would affect all ongoing and planned trials involving its lead drug, called beloranib.

The company also said it would take previous reports of severe blood clotting in ongoing and completed trials into account and screen current participants for pre-existing thrombotic disease.
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Zafgen expects to report results from the late-stage study in the first quarter of the next year and the second late-stage study will begin only after the results from the first study are assessed by the FDA.

The trial involved 108 patients and started in October, 2014. A third of them had given the drug and as many given a placebo. The rest of the participants were randomly administered to either the drug or a placebo.



Source: Medindia
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