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


UCB To Provide More Cimzia Information Following FDA "Complete Response"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

UCB will have to submit "additional information" and clarifications to FDA following receipt of a "complete response" letter from the agency for its PEGylated Fab fragment TNF inhibitor Cimzia (certolizumab pegol) for treatment of Crohn's disease, the company said Dec. 22

You may also be interested in...

UCB Seeks FDA Approval For Cimzia In Rheumatoid Arthritis

FDA has accepted a BLA from UCB for Cimzia (certolizumab pegol) seeking an indication for rheumatoid arthritis, the Brussels, Belgium-based biotech announced Feb. 6. The filing, for monotherapy or treatment in combination with methotrexate, is slated for a standard review, giving the application an early December action date

Humira cleared for Crohn’s

Abbott's tumor necrosis factor inhibitor Humira (adalimumab) gained a Crohn's indication from FDA Feb. 27, and may offer a potential benefit over J&J's Remicade (infliximab) as the first self-administered biologic approved for Crohn's disease. Humira is administered subcutaneously every other week, while Remicade requires an infusion. Previously approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, Humira's new indication is for reducing the signs and symptoms and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have an inadequate response to conventional therapy. Abbott expects Humira to generate peak sales of $500 million in the Crohn's disease indication. UCB had hoped to beat Humira to approval with its Crohn's candidate Cimzia, but received a "complete review" letter from FDA in December (1Pharmaceutical Approvals Monthly January 2007, p.19)...

UCB Modeling Itself After Genentech As Next-Generation Biopharma Firm

UCB’s imminent submission of Cimzia for rheumatoid arthritis slated for the end of the year is another step toward a stronger biotech presence for the company.




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