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

by Vishnuprasad on  October 17, 2015 at 2:26 PM Drug News
RSS Email Print This Page Comment bookmark
Font : A-A+

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

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

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.

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

Post a Comment

Comments should be on the topic and should not be abusive. The editorial team reserves the right to review and moderate the comments posted on the site.
Notify me when reply is posted
I agree to the terms and conditions

Related Links

More News on:

Bariatric Surgery Drug Toxicity Obesity Clinical Trials Clinical Trials - The Past and The Future Clinical Trials - Different Phases of the trial Bulimia Nervosa Body Mass Index Signature Drug Toxicity Liposuction 

News A - Z

A B C D E F G H I J K L M N O P Q R S T U V W X Y Z

News Search

Medindia Newsletters

Subscribe to our Free Newsletters!

Terms & Conditions and Privacy Policy.

Find a Doctor

Stay Connected

  • Available on the Android Market
  • Available on the App Store

News Category

News Archive

Loading...