Belgian firm UCB has filed for approval of its Crohn’s disease treatment Cimzia in the USA, marking its first entry into the biologics market, and said it will follow this up with a submission in the European Union "in a matter of weeks."
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 Centocor’s already-marketed Crohn’s drug Remicade (infliximab), which is given by intravenous injection.
The filing is based on the results of the PRECiSE 1 and PRECiSE 2 clinical trials. Data from the latter, presented last year, showed that the anti-TNF agent achieved a 48% clinical remission rate at six months. It is given once a month after an initial induction regimen.
At present, it is estimated that just 15% of Crohn's sufferers in the USA - and 8% in Europe – receive biologic therapy for the disease, and the availability of Cimzia and other agents could expand the market. One other candidate is Abbott’s Humira (adalimumab), a subcutaneously-delivered TNF blocker that is approved for arthritis and in late-stage clinical testing in Crohn’s.
"There are significant unmet needs among Crohn's patients, so additional therapeutic agents will increase our ability to provide effective long-term relief from this debilitating disease," commented William Sandborn, professor of medicine at the Mayo Clinic College of Medicine in the USA and a leading investigator in the Cimzia clinical trial programme.
In addition to the completed and ongoing studies in Crohn's disease, Cimzia is also being tested in rheumatoid arthritis and psoriasis. The drug was acquired by UCB as part of its £1.5 billion purchase of Celltech in 2004.