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

Lorcaserin Advisory Committee Will Again Be Weighed Down By Safety Concerns

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will revisit Arena’s obesity drug May 10; readjudication finds fewer cancers in rats than previously identified, but new data fails to rule out the 50% increased risk for valvulopathy sought by FDA.

You may also be interested in...



Lorcaserin Makes It Past Panel On The Strength Of Effect In Some Patients

The Endocrinologic and Metabolic Drugs Advisory Committee votes 18-4, with one abstention, in favor of lorcaserin for long-term treatment of overweight and obese individuals.

Lorcaserin Safety Questions Can Be Answered In Post-Market Study, Panel Tells FDA

FDA’s Endocrinologic and Metabolic Advisory Committee backs approval of Arena’s weight-loss drug 18 to 4 with one abstention. Uncertainty over the risk for heart disease remains a prime concern for panel members.

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 Headlines
See All
UsernamePublicRestriction

Register

PS074215

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