FDA requests safety update on UCB's Cimzia before final approval for RA

Belgian drugmaker UCB says that the US Food and Drug Administration has issued a complete response letter to its Biologics License  Application for Cimzia (certolizumab pegol), the first PEGylated  anti-tumor necrosis factor antibody for the treatment of rheumatoid  arthritis. As a prerequisite for approval of Cimzia, the FDA has  requested a new safety update with all clinical findings including new  data generated since the filing of the BLA. The FDA has invited UCB for  a meeting, expected to take place within 30 days, to define the path  forward. On the day of the news, January 5, shares in the firm dropped  6.8% to 24 euros.