Posted by Michael Wonder on 06 Aug 2020
Cimzia is the first and only biologic approved in Europe with the option for a reduced maintenance dose for patients across the full axial spondyloarthritis spectrum
5 August 2020 - European label extended to include a dose reduction option for the treatment of adult patients with axial spondyloarthritis, including non-radiographic and radiographic axial spondyloarthritis, who are in sustained remission after one year of Cimzia (certolizumab pegol) treatment, underpinned by results of the Phase 3b C-OPTIMISE study.
UCB today announced that the European Medicines Agency has approved a label extension for Cimzia (certolizumab pegol) for use in adult patients with axial spondyloarthritis at a reduced maintenance dose of 200 mg every four weeks (Q4W), once sustained remission is achieved after one year of Cimzia 200 mg every two weeks (Q2W) or 400 mg Q4W.
The approval makes Cimzia the only biologic in Europe with a dose reduction option in its label for patients in the broad axSpA population.
