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UCB have announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) relating to the Biologics License Application (BLA) of Cimzia (certolizumab pegol) – the first PEGylated anti-TNF for the treatment of rheumatoid arthritis (RA).
As a prerequisite for approval of Cimzia the FDA has requested a new safety update with all clinical data including new data generated since the filing of the BLA.
The FDA has invited UCB for a meeting, expected to take place within approximately 30 days, to define the path forward.
“UCB is confident and committed to making Cimzia available to people living with moderate to severe rheumatoid arthritis and other inflammatory conditions as soon as possible. UCB will work diligently with the FDA to fulfill their request,” said Prof Dr Iris Loew-Friedrich, chief medical officer of UCB.
The BLA, accepted for filing and review in February 2008, was based on a clinical programme conducted by UCB which included more than 2,300 patients (representing more than 4,000 patient years of experience) involved in several multi-centre placebo-controlled phase III trials.
On April 22, 2008, the FDA approved Cimzia for reducing 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.