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

ESAs in Renal Disease: Amgen Braves an Advisory Committee Storm With Another Regulator in Mind

This article was originally published in RPM Report

Executive Summary

An FDA panel was convened to re-evaluate the cardiovascular risks associated with Amgen’s Aranesp and the ESAs after a third clinical trial showed CV endpoints going in a negative direction. The company was able to emerge from the meeting with a near-best case scenario. That’s critical with a CMS coverage decision looming.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS080745

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