CHMP Backs Cosentyx for Polymyalgia Rheumatica, Setting Up First IL-17A Approval in Europe
核心洞察
The EMA's CHMP has adopted a positive opinion recommending Cosentyx (secukinumab) for adults with polymyalgia rheumatica (搜索) who respond inadequately to steroids or relapse during taper.
If approved by the European Commission, secukinumab would become the first IL-17A inhibitor licensed in Europe for polymyalgia rheumatica (搜索), a disease with few advanced options.
The recommendation rests on the pivotal Phase III REPLENISH trial, in which all primary and secondary endpoints were met in both the 300mg and 150mg arms.
Novartis announced on September 18, 2026 that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (搜索) has adopted a positive opinion recommending marketing authorization for Cosentyx (secukinumab) in polymyalgia rheumatica (搜索) (PMR). The opinion supports use in adults with PMR who have had an inadequate response to steroids or who experience relapse during steroid taper.
If approved, Cosentyx would be the first interleukin-17A (搜索) (IL-17A) inhibitor authorized in Europe for PMR, a disease the company describes as having very limited advanced treatment options. Following the CHMP recommendation, the European Commission is expected to issue a final decision within approximately two months.
REPLENISH Results Underpin the Opinion
The positive opinion is supported by results from the pivotal REPLENISH Phase III trial, in which all primary and secondary endpoints were met across both the Cosentyx 300mg and 150mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 52. Data showed that Cosentyx doubled sustained remission rates and delivered steroid-sparing effects versus placebo, and no new safety signals were identified in PMR patients receiving the drug. The results were published in the New England Journal of Medicine and simultaneously presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress on June 3, 2026.
REPLENISH (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries. Patients were randomized to Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The primary endpoint assessed whether Cosentyx 300mg subcutaneously plus a 24-week steroid taper is superior to placebo plus the same taper in achieving sustained remission at week 52. Key secondary endpoints included the proportion of patients achieving complete sustained remission at week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through week 52.
"The introduction of Cosentyx to the PMR space represents a major advancement for patients and clinicians, providing an effective treatment option while also reducing reliance on steroids, which can present challenges with long-term use," said Prof Christian Dejaco, Director, Department of Rheumatology, South Tyrol Health Trust, Bruneck, Italy. "I am encouraged by this positive CHMP opinion for a treatment which could both reduce flares and lower patients' steroid exposure."
Unmet Need in a Steroid-Dependent Disease
PMR is a common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized 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.
"People living with PMR need treatments that provide lasting remission, prevent relapses and are well-tolerated, in order to achieve the best possible long-term outcomes," said Patrick Horber, M.D., President, International, Novartis. "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. Today's 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."
Established Autoimmune Footprint
Cosentyx is a fully human biologic that directly inhibits interleukin-17A (搜索), a cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved in adults for psoriatic arthritis (搜索) (PsA), moderate to severe plaque psoriasis (搜索) (PsO), ankylosing spondylitis (搜索) (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (搜索) (HS). The drug is also approved in pediatric patients, including those with PsO, juvenile idiopathic arthritis subtypes such as juvenile psoriatic arthritis (JPsA) and enthesitis-related arthritis (ERA), and in the U.S. for pediatric patients aged 12 years and older with moderate to severe HS and juvenile AS.