Novartis’ Cosentyx (secukinumab) has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending marketing authorisation in polymyalgia rheumatica (PMR).
The opinion supports Cosentyx use for treatment of PMR in adults who have had an inadequate response to steroids or who experience relapse during steroid taper. If approved, Cosentyx would be the first interleukin-17A (IL-17A) inhibitor approved in Europe for people living with PMR, a disease with very limited advanced treatment options.
PMR is a common inflammatory rheumatic disease in adults aged 50 years and older, typically characterised by acute pain and stiffness in the shoulders, neck and hips. Relapses are frequent, affecting up to 40% of patients in the first year. Long-term steroid use is the current standard of care and carries significant risks, including osteoporosis and diabetes. Beyond physical complications, PMR substantially impairs quality of life through pain, fatigue, restricted mobility and fear of relapse.
The positive CHMP opinion is supported by results from the pivotal REPLENISH phase 3 trial. The data was published in the New England Journal of Medicine and simultaneously presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress.
Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS).
Patrick Horber, President, International, Novartis, said: “Cosentyx is the first and only anti-IL-17A shown to provide sustained remission in patients with PMR, and its approval would represent an important step in transforming care for those living with this disease. This positive opinion builds on the well-established impact of Cosentyx in autoimmune disease and could help establish a new standard of care for PMR in Europe.”
Following the CHMP recommendation for approval, the European Commission (EC) is expected to issue a final decision within approximately two months.