Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Obesity Drugs Panel To Mull Whether Products Without CV Signal Need Outcomes Trial

This article was originally published in The Pink Sheet Daily

Executive Summary

The Endocrinologic and Metabolic Drugs Advisory Committee also will evaluate methods for collecting cardiovascular risk information for obesity drugs with a CV safety signal, as FDA seeks input on when and how sponsors should evaluate their products.

You may also be interested in...



FDA Clears Belviq With Post Hoc Finding Of Less Than Double Placebo CV Risk

In analyses of both a narrow and a broad search for cardiovascular events in lorcaserin’s clinical trials, the upper bound of the 95% confidence level was less than 2.0, allowing marketing with a full CV outcomes trial to come post-approval, FDA briefing documents reveal.

CV Trials For Obesity Drugs Won’t Be Conducive To Easy Interpretation, Panel Indicates

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will discuss design issues March 29 and vote on the need for pre-approval trials in drugs without a CV safety signal.

Orexigen Agreement On Contrave CV Trial Hints At FDA’s Thinking On Obesity

FDA appears to be testing weight loss agents against an easier-to-meet threshold for cardiovascular risk compared to diabetes drugs, based on Orexigen Therapeutics Inc.’s announcement of an agreement with the agency on a cardiovascular outcomes trial for its obesity agent Contrave (naltrexone/bupropion).

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS073930

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel