EMA expands label for UCB’s Cimzia in axial spondyloarthritis
pharmafile | August 5, 2020 | News story | Research and Development, Sales and Marketing | Cimzia, EMA, Europe
The European Medicines Agency has expanded the existing approval of UCB’s Cimzia (certolizumab pegol) to cover the treatment of axial spondyloarthritis (axSpA) with a reduced maintenance dose of 200 mg every four weeks in patients who have achieved sustained remission after taking a 200mg dose every two weeks or a 400mg dose every four weeks for a year.
The decision means that Cimzia is the only biologic medicine available for this indication in Europe with a dose reduction option.
Phase 3 data supporting the approval showed that 43.9% of 736 patients with early active axSpA achieved sustained remission after 48 weeks, with almost all of that number receiving 200mg Cimzia either every two or four weeks, or placebo. After 96 weeks, 84% and 79% of the two Cimzia groups respectively remained free of flare ups, compared to just 20% of placebo patients.
Furthermore, 60% of patients receiving Cimzia every four weeks who experienced flare ups regained remission 12 weeks after shifting to receive Cimzia every two weeks instead. There was no reported difference in responses between patients with radiographic axSpA (r-axSpA) and non-radiographic axSpA (nr-axSpA).
Emmanuel Caeymaex, UCB’s Executive Vice President Immunology Solutions and Head of US, said the study was the “first and only randomised controlled trial to compare both maintenance dose continuation and dose reduction versus placebo in a broad axSpA population. Taken with previous clinical evidence showing that early treatment of axSpA with Cimzia provides improved clinical outcomes, axSpA patients have a treatment option that can help address their symptoms at every stage of their disease: from initiation of biologic therapy, to remission and maintenance. Our clinical study package in axSpA showed that r-axSpA and nr-axSpA are part of the same disease entity. If treated early, remission is a realistic target and patients can have the flexibility to reduce their dose once they have achieved sustained remission.”
Matt Fellows
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