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

FDA Reviewers Say Vorapaxar Approvable, But Question Study Changes

This article was originally published in The Pink Sheet Daily

Executive Summary

As the platelet inhibitor heads to an advisory committee, agency reviewers raise issues about safety-based changes to its Phase III trials.

You may also be interested in...



Merck’s Zontivity Label Isn’t Weighed Down With Safety Language

FDA approves antiplatelet inhibitor with a label that makes little mention of the safety concerns seen in lightweight patients, despite a vibrant FDA and advisory panel discussion on how to present the unfavorable data, but the company still has a big marketing challenge ahead.

Janssen Faces Prospect Of New Trial For Xarelto ACS Claim

Cardio-renal advisory committee recommends against rivaroxaban’s approval for acute coronary syndromes and says exploratory analyses on duration of use could be used to design a new study. Panelists also had some thoughts on whether, and how, to study anticoagulants for acute treatment and chronic use together.

Merck’s Vorapaxar Overcomes Trial Questions, Committee Recommends Approval

FDA’s Cardiovascular and Renal Drugs Advisory Committee says that TRA2P trial’s interim analysis issues did not affect interpretation of its results.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS076366

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