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

Arthritis Development Strategy: Cimzia’s BLA Has More Wiggle Room, But Humira Uses Tougher Endpoint

This article was originally published in The Pink Sheet Daily

Executive Summary

Heading into a July 23 Arthritis Advisory Committee, AbbVie’s Humira brings a robust efficacy showing but also total reliance on a new patient diagnostic mechanism; the product’s supplemental application will be reviewed alongside a similar one for UCB’s Cimzia.

You may also be interested in...



Arthritis Patient Classification To Be Key Issue In TNF Inhibitor Reviews

FDA’s Arthritis Advisory Committee will meet July 22 to give its views on how identification criteria for axial spondyloarthritis impacts approval of drugs for the disease; sBLAs seeking the indication for AbbVie’s Humira and UCB’s Cimzia are pending at the agency.

Humira Shows Benefit In New Arthritis Indications Based On Novel Criteria

Abbott’s anti-TNF demonstrated an improvement in two subsets of spondyloarthritis patients using new criteria developed by the SpondyloArthritis International Society to identify and test patients.

Woodcock Takes On Rare Disease Challenges In Retirement, Keeps FDA, Industry At Arm’s Length

Recently retired US FDA Principal Deputy Commissioner Janet Woodcock will be advising the Haystack Project, with the goal of helping rare disease organizations encourage creativity in drug development programs without jeopardizing regulatory success, Woodcock told the Pink Sheet in an interview.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS075901

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