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


Zortress Approval Delay Caused By Novartis Attempts To Avoid Controlled Trial Of Dosing Regimen

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Sponsors cannot cut corners in developing clinical data to support a revised dosing scheme, even when a drug’s efficacy has already been shown, Novartis learned while shepherding its kidney transplant agent Zortress (everolimus) through the FDA approval process.

You may also be interested in...

Kidney Transplant Endpoints Strive For Acceptance At FDA Workshop

Traditional endpoints are becoming increasingly difficult to use successfully in clinical trials because the standard of care has become highly effective.

Out Of The Shadow Of REMS: FDA Review Documents Show Emerging Importance Of Post-Marketing Requirements

Although often overshadowed by the novelty of FDA’s sweeping authority in constructing Risk Evaluation and Mitigation Strategies, examination of agency review documents suggest that the FDA Amendments Act’s other safety innovation, granting FDA the ability to require (i.e., enforce) post-marketing studies, is increasingly important to the approval of NDAs with marginal data on issues of concern.

Behind The Approval Letter: A Year Of Drug Review Profiles

Related Content





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