Belgian drugmaker UCB has submitted a Marketing Authorization Application to the European Medicines Agency (EMEA) for the approval of Cimzia as a treatment for patients with Crohn's disease.
If approved, Cimzia (certolizumab pegol; CDP870) would be the first biologic drug available for the treatment of Crohn's disease that would be delivered by subcutaneous injection.
It works by inhibiting tumor necrosis factor, the same underlying mechanism as Johnson & Johnson’s already-marketed Crohn's drug Remicade (infliximab), which is given by intravenous injection. At present, it is estimated that just 8% of Crohn’s sufferes in Europe receive treatment with a biologic agent for their condition, a proportion that could increase if Cimzia is approved for marketing.
The European submission follows the filing of a Biologics License Application for Cimzia to the US Food and Drug Administration (FDA) in March.
The firm noted that the European submission is based on safety and efficacy data from two pivotal Phase III studies with over 1,500 Crohn’s disease patients, demonstrating Cimzia's sustained and consistent efficacy.
Cimzia is also in trials for the treatment of rheumatoid arthritis and psoriasis.