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

Gilead’s Quad Makes It Through FDA Panel Review Despite Renal Safety Concerns

This article was originally published in The Pink Sheet Daily

Executive Summary

Antiviral Drugs Advisory Committee votes 13-1 in favor of the four-drug-in-one HIV treatment. Panel members offer a host of suggestions for post-marketing studies, including determining the best means for detecting Quad-related renal injury early.

You may also be interested in...



Mutation Resistance Could Differentiate Shionogi/ViiV’s Dolutegravir

Full data from the Phase III SPRING-2 trial released at the International AIDS Conference revealed ViiV/Shionogi’s experimental integrase inhibitor dolutegravir had no resistance mutations compared to Merck’s Isentress.

Renal Safety In The Spotlight At FDA Panel Review Of Gilead’s Quad

The four-drug, single-tablet HIV treatment regimen was associated with higher rates of serious adverse events and study drug discontinuations due to renal events in the pivotal trials. FDA is seeking the Antiviral Drugs Advisory Committee’s views on renal safety and whether monitoring recommendations should be stricter than those proposed by Gilead.

US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects

CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS074107

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