Also in the news, the Belgian pharmaceutical group UCB presented data showing that its drug, Cimzia, significantly reduces joint damage from RA and that a high dosage (400 mg injection every other week) may even act to repair joints. The randomized trials studied Cimzia in combination with methotrexate and like most of the other studies with this comparison, found that it was more effective together than methotrexate alone. The study showed that it inhibits the progression of joint damage for up to one year. Cimzia in an anti-TNF inhibitor, like Enbrel, Remicade and Humira.
Cimzia is not without its problems though. UCB has already filed the drug for approval in both the US and EU for the treatment of Chrohn's disease. But recently the EMEA (European Agency for the Evaluation of Medicinal Products), Committee for Medicinal Products for Human Use (CHMP) gave a negative opinion on Cimzia, as treatment for Crohn's disease. UCB will have to address several specific issues raised by the CHMP in order to gain approval by mid-2008. The company has said it will submit an appeal on the decision. And earlier this year, in March 2007, the FDA told UCB that it will need to conduct another trial of patient's clinical response to Cimzia for the treatment of Crohn's disease before approval of the drug can be reconsidered. These negative responses from government regulatory agencies will delay Cimzia for possibly several years. Plus, even if it is approved for Chrohn's disease first, it is possibly several years away from approval for RA. Since it is so far behind the other three established anti-TNF inhibitors, it will have to show some pretty great results in order to gain a following of patients and physicians.
