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

Novartis Exjade Trial Failed To Show Non-Inferiority To Desferal, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Subset analysis conducted by Novartis may show Exjade benefit in certain patients at higher doses, according to FDA background documents for the Sept. 29 Blood Products Advisory Committee meeting.

You may also be interested in...



Novartis' Exjade Recommended For Approval Under Broader Indication

FDA's Blood Products Advisory Committee agreed that data for the oral chelating agent from primarily thalassemia patients may be extrapolated to transfusional hemosiderosis.

Novartis' Exjade Recommended For Approval Under Broader Indication

FDA's Blood Products Advisory Committee agreed that data for the oral chelating agent from primarily thalassemia patients may be extrapolated to transfusional hemosiderosis.

Novartis' Exjade Goes To Blood Products Committee Sept. 29

Advisory committee likely to discuss iron chelator’s failure to show non-inferiority to existing treatment in 1,000-patient clinical program.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062965

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