UCB obtains FDA complete response letter for arthritis drug

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 biologics license application (BLA). The FDA has invited UCB for a meeting, expected to take place within approximately 30 days, to define the path forward.

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 involved in several multi-centre placebo-controlled Phase III trials.

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 rheumatoid arthritis.

Iris Loew-Friedrich, chief medical officer of UCB, said: 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.