Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Phase IV Proof of Efficacy: A Brilinta Idea?

This article was originally published in RPM Report

Executive Summary

AstraZeneca won two strong votes in favor of approval of its clot-busting drug Brilinta (ticagrelor) from FDA's Cardio-Renal Drugs Advisory Committee on July 28. Standing between the drug and final FDA approval, however, is an unusual request from the advisory committee for a supporting Phase IV efficacy study in the same indication as approval. That's a sign of the troublesome advice that FDA is getting on post-maketing studies form advisory committees.

You may also be interested in...



IoM Will Address Ethics in Safety Studies Prior To Avandia Advisory Committees

FDA is acting to create political and scientific cover for the second public review of Avandia safety issues in mid-July. A former top staffer to House Energy & Commerce Chairman Waxman is doing an internal study of agency post-marketing safety procedures to assure Capitol Hill that FDA takes the issue seriously; an IoM workshop is convening in early June to prepare a preliminary review on the ethical issues with post-market safety studies.

FDAAA Impact (Year Two): More of Everything

The second year of the FDAAA-era is over, and FDA is using its new drug safety tools (Risk Evaluation & Mitigation Strategies and mandatory post-marketing studies) more often. Not only are more drugs requiring REMS and mandatory trials, the burden of those programs is increasing.

The Prasugrel Backlash: Another Black Eye for FDA's Advisory Committee Process

FDA is the first to acknowledge that a lot of things went wrong during the run-up to the prasugrel advisory committee meeting, not the least of which is how the agency handles allegations of intellectual bias among its members. For drug sponsors, it may mean that the rules of engagement have changed.

Related Companies

UsernamePublicRestriction

Register

PS080728

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