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

Potential Cardiovascular Benefit Colors CV Safety Expectations For Obesity Drugs

Executive Summary

Only a superiority trial could give certainty of CV safety for weight-loss medications prior to approval, FDA’s Robert Temple tells the Endocrinologic and Metabolic Drugs Advisory Committee.

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.

Could Enrichment Cloud CV Signal For Weight-Loss Drugs?

FDA’s Robert Temple says the trend in risk indicators is the important element when interpreting data from high-risk patients for low-risk patients, after some advisory panel members question the relevance of data from older, sicker participants to the younger patients who take obesity products.

CV Risk Assessment For All Obesity Drugs Seems Inevitable Pre-Approval Requirement

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee March 29 voted 17-6 that all obesity drugs should be vetted for cardiovascular risk, but some could rely on a meta-analysis rather than an outcomes trial.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS054352

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