Tags: FDA | obesity | drugs | new drugs | health

FDA Halts New Obesity Drug Study After Patient Dies

FDA Halts New Obesity Drug Study After Patient Dies
 

Friday, 16 October 2015 01:01 PM EDT

 
Zafgen Inc said the U.S. Food and Drug Administration has put a partial hold on the development of its obesity treatment and confirmed that the 22-year-old patient who died during a late-stage study had been taking the drug.

The company's stock plunged 35 percent to $13.52 in early trading on Friday.

The company, which focuses on drugs for metabolic disorders, said the partial hold would affect all ongoing and planned trials involving its lead drug, called beloranib.

Due to previously reported instances of severe blood clotting in ongoing and completed trials, Zafgen said it would screen current participants for pre-existing thrombotic disease.

Zafgen expects to report results from the late-stage study in the first quarter of 2016 as the trial is nearly complete.

A second late-stage study planned on the drug will start only after the results from the first study are assessed by the FDA, the company said.

A partial clinical hold is an order the FDA issues to delay or suspend part of a company's clinical study.

Zafgen said on Wednesday the patient died during the late-stage trial testing the drug to treat Prader-Willi syndrome, a rare genetic disorder that leads to obesity.

The trial involved 108 patients, with a third of them given the drug and as many given a placebo. The rest of the patients were randomly given either the drug or a placebo.

The beloranib trials started in October last year and the drug had passed all safety tests conducted by experts, analysts said.

Prader-Willi syndrome is the most common genetic cause of life-threatening obesity. People with the disorder have an unrelenting hunger that drives them to overeat, which leads to excessive weight gain.


(Reporting by Amrutha Penumudi in Bengaluru; Editing by Don Sebastian)


© 2024 Thomson/Reuters. All rights reserved.


Health-News
Zafgen Inc said the U.S. Food and Drug Administration has put a partial hold on the development of its obesity treatment and confirmed that the 22-year-old patient who died during a late-stage study had been taking the drug.
FDA, obesity, drugs, new drugs, health
289
2015-01-16
Friday, 16 October 2015 01:01 PM
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