UCB Receives CHMP Positive Opinion for Cimzia in Active PsA
UCB has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending extending the European Union marketing authorization for the use of Cimzia® (certolizumab pegol) in the treatment of adult patients with active psoriatic arthritis (PsA).
PsA is a chronic, inflammatory condition that causes pain, swelling and stiffness in and around the joints and tendons and usually occurs in combination with psoriasis. In most people with PsA, psoriasis develops before joint problems.
When hands and feet are affected in PsA, nail changes can occur as well as swelling in the fingers and toes (dactylitis). PsA affects an estimated 24 in 10,000 people and affects up to 30% of psoriasis patients. It usually occurs between the ages of 30 and 50.
The long-term burden of PsA is substantial with over half of patients developing progressive, erosive disease with functional impairment.
“This CHMP positive opinion for Cimzia® in active PsA closely follows the European approval of Cimzia® for the treatment of adults with severe active axial spondyloarthritis and illustrates our commitment to the wider population of people in Europe with rheumatology conditions who need innovative, new treatment options,” said Professor Dr. Iris Loew-Friedrich, Chief Medical Officer and Executive Vice President UCB.
Dr. Loew-Friedrich continued, “Results from the RAPID™- PsA study supporting the positive opinion showed that treatment with Cimzia® improved the clinical signs and symptoms of PsA, including arthritis, enthesitis, dactylitis and skin involvement, with a rapid onset of action.”
The CHMP recommendation forms the basis for a European Commission licensing decision, which is expected in approximately two months.
The positive opinion follows the EMA’s review of data from the RAPID™-PsA study, an on-going, Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of certolizumab pegol in patients with adult onset active and progressive PsA.
In the European Union, certolizumab pegol is approved in combination with methotrexate (MTX) for the treatment of moderate to severe active rheumatoid arthritis in adult patients inadequately responsive to disease-modifying anti-rheumatic drugs, including MTX.
Certolizumab pegol can be given as monotherapy in case of intolerance to MTX or when continued treatment with MTX is inappropriate.
In addition the European Commission has recently approved certolizumab pegol for the treatment of adult patients with severe active axial spondyloarthritis (axSpA) comprising (1) Ankylosing spondylitis (AS) - adults with severe active AS who have had an inadequate response to, or are intolerant to non-steroidal anti-inflammatory drugs (NSAIDs); (2) Axial spondyloarthritis without radiographic evidence of AS - adults with severe active axSpA without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and/or MRI, who have had an inadequate response to, or are intolerant to NSAIDs.