Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.UCB has said that US health authorities have requested an additional study examining its Crohn's disease drug Cimzia, potentially delaying its entry to the market.
Subscribe to our email newsletter
The FDA did not raise any concerns about the safety of Cimzia or any issues concerning chemistry, manufacturing and controls but asked for an extra study because of the inadequacy of one study design.
“We have complete confidence in Cimzia’s robust efficacy and competitive safety,” said CEO Roch Doliveux.
UCB has said it will work closely with the FDA to finalize the design of the clinical study which will be conducted to provide additional clinical efficacy data. UCB expects the results from this additional study in the second half of 2008.
The initial Cimzia development program for the treatment of Crohn’s disease met all primary endpoints with statistical significance. Cimzia is the first and only PEGylated anti-TNF (Tumor Necrosis Factor) antibody. Cimzia is designed to retain the potency of the original antibody without the possible cytotoxicity mediated by the Fc portion present in conventional anti-TNFs.
UCB plans to file a biologics license application with the FDA for Cimzia in the treatment of rheumatoid arthritis by year end 2007.