Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

sections

Adverse drug reactions

Second clinical trial death puts the future of obesity drug in doubt

The FDA has told Zafgen that its investigational new drug application for obesity, beloranib, has been put on hold after the death of a patient with Prader-Willi syndrome (PWS) during a clinical trial. In the image, x-ray of a patient's head with PWS

Source: Zephyr / Science Photo Library

The trial was assessing the effects of investigational drug beloranib in patients with Prader-Willi syndrome (pictured), a congenital syndrome characterised by learning disability and obesity

The US Food and Drug Administration (FDA) has given pharmaceutical company Zafgen a verbal notice that its investigational new drug application for obesity treatment beloranib has been put on complete clinical hold after the death of a patient during a phase III clinical trial.

The trial was evaluating the drug in patients with Prader-Willi syndrome (PWS), a congenital syndrome characterised by short stature, learning disability and polyphagia with marked obesity.

The notice was given six weeks after an earlier fatality on the trial, after which beloranib had been put on partial clinical hold by the FDA. The death of this second patient enrolled on the Phase III ZAF-311 bestPWS clinical trial, following a bilateral pulmonary emboli, puts the future of the programme in doubt, according to analysts.

“We are working diligently to assemble and analyse the data from our ZAF-311 clinical trial to be able to provide a clear view of the safety and efficacy of beloranib in the PWS population,” says Thomas Hughes, chief executive of Zafgen.

“Together with PWS and thrombosis experts, we are developing a comprehensive approach to better understand the incidence and mechanisms underlying thromboembolic disease in the setting of PWS,” he adds.

Patients with PWS have a variety of health issues that can shorten life expectancy. According to Hughes, the average life expectancy is estimated to be 30–32 years.

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2015.20200218

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Patient Care in Community Practice

    Patient Care in Community Practice

    Patient Care in Community Practice is a unique, practical guide for healthcare professionals or carers. Covers a range of non-medicinal products suitable for use at home.

    £22.00Buy now
  • Clinical Pharmacokinetics

    Clinical Pharmacokinetics

    A practical guide to the use of pharmacokinetic principles in clinical practice. Includes case studies with questions and answers.

    £33.00Buy now
  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • The FDA has told Zafgen that its investigational new drug application for obesity, beloranib, has been put on hold after the death of a patient with Prader-Willi syndrome (PWS) during a clinical trial. In the image, x-ray of a patient's head with PWS

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.