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
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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. The firm submitted the certolizumab BLA on Feb. 28. UCB is aiming for the first subcutaneous injection for Crohn's, although now Abbott's Humira (adalimumab) may win that title with an estimated March 7, 2007 user fee date. "We have absolute confidence in both the efficacy and tolerability profile of Cimzia, and in gaining U.S. approval," UCB VP Research and Development Melanie Lee said. Johnson & Johnson's Remicade (infliximab) is currently the only TNF inhibitor indicated for Crohn's. Its next-generation TNF inhibitor, golimumab, also recently suffered a setback when the firm announced it halted Phase III trials due to distribution issues. J&J is working on both subcutaneous and intravenous formulations. UCB also announced results from two rheumatoid arthritis Phase III trials for certolizumab. "Cimzia, in combination with methotrexate, demonstrated superiority to placebo, and statistically significant improvement in the signs and symptoms of rheumatoid arthritis as measured by all American College of Rheumatology (ACR) scores: ACR 20, 50 and 70," the firm said. The Belgian firm said at its September R&D day in London that it was planning an sBLA for rheumatoid arthritis by year's end (1 Pharmaceutical Approvals Monthly September 2006, p. 8). FDA's decision is a setback for UCB in expanding its U.S. presence as it prepares for the loss of patent protection in June 2008 on its anti-epileptic Keppra (levetiracetam). The company filed a citizen petition with the agency in October and is also developing a once-daily levetiracitam formulation to continue the franchise. However, UCB could get a boost this year following the June submission of the allergy agent Xyzal (levocetirizine dihydrochloride), which will be copromoted with Sanofi-Aventis. [Editors' note: A version of this story first appeared in "The Pink Sheet" DAILY Dec. 22, 2006. Visit our website, 2 www.thepinksheetdaily.com , to sign up for a free trial.] |