UCB To Provide More Cimzia Information Following FDA "Complete Response"
This article was originally published in Pharmaceutical Approvals Monthly
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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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
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’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.