UCB announced that it met the U.S. Food and Drug Administration (FDA) and clarified the requirements for the approval of the Biologics License Application (BLA) for Cimzia®, the first PEGylated anti-TNF, for the treatment of rheumatoid arthritis (RA).
During the meeting, the FDA communicated that they require further analysis of existing data and a new safety update. No additional studies (clinical or non-clinical) are needed to fulfill this request.
"UCB is working diligently with the FDA to fulfil its request and, due to the already rich database available for Cimzia® in rheumatoid arthritis, we anticipate submitting the full response for Cimzia® in the second quarter of this year," said Prof. Dr. Iris Loew-Friedrich, Chief Medical Officer of UCB.
In January this year, UCB received a Complete Response Letter from the FDA in connection with the Cimzia® BLA. The BLA, accepted for filing and review in February 2008, was based on a clinical program conducted by UCB which included more than 2,300 patients, representing more than 4,000 patient years of experience and involved several multi-centre placebo-controlled Phase III trials.
On April 22, 2008, the FDA approved Cimzia® for reducing the signs and symptoms of Crohn's disease, and maintaining clinical response, in adult patients with moderate to severe active disease that have had an inadequate response to conventional therapy. Cimzia® is also approved in Switzerland for the induction of a clinical response, and for the maintenance of a clinical response and remission, in patients with active Crohn's disease who have not responded adequately to conventional treatment.
Cimzia® is also undergoing active review by the European authorities for the treatment of RA.