UCB says that European regulators have accepted the firm’s anti- tumour necrosis factor agent Cimzia for review as a treatment for adults with moderate to severe active rheumatoid arthritis.
The Belgium-headquartered company noted that a marketing authorisation application has been submitted to the European Medicines Agency and if it is approved Cimzia (certolizumab pegol) will be the first PEGylated, anti-TNF biologic therapy available in Europe for the treatment of RA.
The filing is based on data from more than 2,300 patients totalling over 4,000 patient-years of experience and Cimzia has been studied at two or four week dosing intervals, and administered together with methotrexate or as monotherapy. Earlier this month, UCB presented data from analyses of its RAPID 1 and 2 studies at the European League Against Rheumatism meeting in Paris which suggest that Cimzia may be the fastest-acting anti-TNF drug when added to MTX.
Olav Hellebo, president of inflammation operations at UCB, said that along with a fast onset of action, Cimzia has been shown to rapidly reduce the rate of progression of joint damage “and to improve measurements of patients’ physical function”. He added that the drug “will provide a new and effective treatment option for this debilitating condition”.
The European review follows a filing of Cimzia to the US Food and Drug Administration in February for the treatment of RA, while the agency approved the drug as a treatment for Crohn’s disease in April. However the RA market is much more lucrative and UCB is hoping that Cimzia could help plug the gap in sales resulting from the loss of patent protection on its biggest earners – the allergy drug Zyrtec (cetirizine) and the antiepileptic Keppra (levetiracetam).
If approved, Cimzia will battle for market share with three other TNF blockers that are marketed for RA – Johnson & Johnson/Schering-Plough’s Remicade (infliximab), Abbott Laboratories’ Humira (adalimumab) and Amgen and Wyeth’s Enbrel (etanercept).
