In Vivo 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

Ilaris Complete Response Letter Raises Questions About The Validity of Priority Review Vouchers

Executive Summary

What’s a Priority Review Voucher worth? That’s a complicated question now that the first voucher used on an application, from drug maker Novartis AG for Ilaris (canakinumab), has received a complete response letter from US regulators.

You may also be interested in...



Novartis Takes Stock Of Ilaris For Gout Following FDA's Complete Response Letter

The agency seeks more clinical data on canakinumab in refractory patients after an advisory committee meeting that focused on the drug's potential risks.

How Much Is A Priority Review Voucher Worth? Perhaps $387 Mil.

There's no real market for priority review vouchers; indeed, it seems like there is only one voucher in existence at the moment – Novartis' coupon from the Coartem approval.

Priority Review Voucher's Uncertain Value May Hinder Development

FDA’s innovative priority review voucher, intended to incentivize the development of new drugs for neglected diseases, may actually have created a hurdle in some cases.

Related Content

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

IV003701

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