UCB files in EU for Cimzia in rheumatoid arthritis
This article was originally published in Scrip
UCBhas filed for EU approval of Cimzia (certolizumab), its humanised anti-TNF antibody fragment, in rheumatoid arthritis.
UCB applied for US approval in RA in February. Both filings included data from the RAPID-1 and RAPID-2 trials in which Cimzia, given with methotrexate, demonstrated a reduction in signs and symptoms of active RA and inhibited progression of structural damage in patients who had failed on methotrexate, with results maintained for up to a year. The results of the trials were presented at last year's American College of Rheumatology meeting (Scrip No 3312, p 24).
If approved, Cimzia would compete with three other anti-TNF therapies indicated for RA in the EU: Abbott's Humira (adalimumab), Amgen/Wyeth's Enbrel (etanercept) and Johnson & Johnson's Remicade (infliximab). In future, it could also face competition from Centocor’s (Johnson & Johnson’s) investigational anti-TNF golimumab, which was filed in the EU in February, and in the US this month, for use in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.
UCB has already tried to obtain EU approval of Cimzia in Crohn's disease, but the EU's CHMPissued a negative opinion on that application last November and confirmed its rejection in March following an appeal. In April, Cimzia was approved in the US for use in Crohn's disease, its first indication there.