Pfizer’s blockbuster arthritis drug Enbrel (etanercept) has won a new indication in Europe to treat early-stage inflammatory joint disease.
The European Commission gave the green-light to a label extension for Enbrel in the treatment of adult patients with severe non-radiographic axial spondyloarthritis (nr-axSpA).
The third best-selling drug in the world last year, Enbrel’s latest indication puts the drug on a par with its rival TNF-inhibitors Humira and Cimzia and gives it a slight advantage over Remicade.
axSpA is a painful and progressive type of arthritis that affects the hip and lower spine joints and patients with the non-radiographic form are still in the early stage of the disease – experiencing symptoms before structural changes can be detected by x-ray.
axSpA is estimated to affect between 0.3 and 1 per cent of the adults and up to 12 per cent of patients with the chronic lifelong inflammatory disease nr-axSpA will progress to the more serious ankylosing sponylitis within two years.
Dr Berkeley Phillips, Pfizer UK’s medical director, said “This licence extension reflects Pfizer’s continuing commitment to enhancing the scientific community’s understanding of rheumatic diseases and providing treatment options for patients to address an unmet need in this less well-understood but equally painful form of spondyloarthritis.”
The European Commission’s approval decision was based on data from Study 1031, which showed 32.4 per cent of Enbrel patients showed significant improvements compared to 15.7 per cent of those receiving a placebo. Treatment related adverse events were reported in 57 per cent and 45 per cent of patients in the etanercept and placebo groups, respectively.
The EC approval is for the treatment of adults with severe non-radiographic axSpA with objective signs of inflammation as indicated by elevated CRP and/or MRI evidence, who have had an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs).