Novartis’ Cosentyx Receives Positive CHMP Opinion for Polymyalgia Rheumatica in Europe
Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Cosentyx® (secukinumab) for the treatment of polymyalgia rheumatica (PMR) in Europe. The recommendation marks an important regulatory milestone for a disease in which treatment has traditionally relied heavily on corticosteroids and where patients who experience relapses or inadequate responses can face significant treatment challenges.
If approved by the European Commission (EC), Cosentyx would become the first interleukin-17A (IL-17A) inhibitor approved in Europe for adults living with PMR. The proposed indication is for adults who have an inadequate response to steroids or who experience a relapse while their steroid treatment is being tapered.
The CHMP recommendation is based on positive results from the pivotal Phase III REPLENISH trial, in which Cosentyx demonstrated efficacy across both the 300 mg and 150 mg treatment groups. The study met all primary and secondary endpoints, including measures of complete sustained remission and the time until patients required additional treatment through week 52.
For patients and physicians managing PMR, the potential availability of a targeted treatment option could represent a significant development, particularly for individuals who struggle to achieve sustained disease control with corticosteroid therapy alone.
Addressing Treatment Challenges in Polymyalgia Rheumatica
Polymyalgia rheumatica is an inflammatory rheumatic condition that primarily affects older adults. The disease can cause substantial pain and stiffness, particularly around the shoulders and hips, and may significantly interfere with everyday activities and quality of life.
Corticosteroids are widely used as the mainstay of PMR treatment. While steroids can provide effective control of symptoms and inflammation, long-term exposure can create treatment challenges. Patients may require extended courses of therapy, and attempts to reduce the steroid dose can sometimes be followed by disease relapse.
This creates a difficult balance for clinicians: controlling inflammation and preventing flares while limiting prolonged exposure to corticosteroids.
The potential role of Cosentyx in PMR is therefore particularly relevant for patients who do not respond adequately to steroids or whose disease returns during steroid tapering.
Prof. Christian Dejaco, Director of the Department of Rheumatology at the South Tyrol Health Trust in Bruneck, Italy, said the potential introduction of Cosentyx into the PMR treatment landscape could provide an effective option while reducing dependence on steroids.
According to Dejaco, the positive CHMP opinion is encouraging because a treatment that can reduce flares and lower steroid exposure could address important challenges faced by people with PMR.
REPLENISH Phase III Trial Supports Recommendation
The positive CHMP opinion is supported by results from the pivotal REPLENISH Phase III trial. The study evaluated Cosentyx at both 300 mg and 150 mg doses and met all of its primary and secondary endpoints.
Among the outcomes evaluated were complete sustained remission and the time until patients needed additional treatment through week 52.
Sustained remission is an important treatment goal in PMR because controlling symptoms for a limited period may not be sufficient if patients subsequently experience another flare. Relapses can require additional treatment and may lead to renewed or prolonged corticosteroid exposure.
The REPLENISH findings therefore provide evidence supporting Cosentyx as a potential treatment capable of maintaining disease control over an extended period.
Novartis reported that no new safety signals were identified among PMR patients receiving Cosentyx. The safety findings add to the broader clinical experience with the medicine in autoimmune and inflammatory diseases.
The REPLENISH data were published in the New England Journal of Medicine and presented at the 2026 European Alliance of Associations for Rheumatology (EULAR) Congress on June 3, 2026.
The publication and presentation of the Phase III findings provide further visibility into the clinical evidence supporting the potential expansion of Cosentyx into PMR.
First Potential IL-17A Inhibitor for PMR in Europe
Cosentyx belongs to a class of targeted medicines known as IL-17A inhibitors. The drug specifically targets interleukin-17A, an inflammatory signaling protein involved in immune-mediated disease.
According to Novartis, Cosentyx is the first and only anti-IL-17A therapy shown to provide sustained remission in patients with PMR.
If the European Commission grants marketing authorization following the CHMP recommendation, Cosentyx would become the first IL-17A inhibitor approved in Europe for PMR.
This would expand the therapeutic options available to rheumatologists treating adults with PMR, particularly patients whose disease remains inadequately controlled with steroids or who experience disease recurrence during steroid reduction.
The potential approval also represents an expansion of the clinical application of Cosentyx beyond its existing autoimmune and inflammatory disease uses.
Focus on Sustained Disease Control
Patrick Horber, M.D., President, International, Novartis, emphasized the importance of achieving lasting remission and preventing relapses for people living with PMR.
Horber said patients need treatments that can provide sustained disease control while being well tolerated and supporting better long-term outcomes.
He described Cosentyx as the first and only anti-IL-17A therapy shown to provide sustained remission in PMR and said the potential approval could represent an important step in changing how the disease is treated in Europe.
The positive CHMP opinion builds on Cosentyx’s established clinical experience in autoimmune disease and highlights the company’s efforts to explore the medicine’s potential across additional inflammatory conditions.
For PMR, the central consideration is not only achieving an initial response but maintaining control while reducing the challenges associated with long-term steroid treatment. The REPLENISH results are therefore particularly relevant because the trial assessed outcomes over 52 weeks and included measures related to sustained remission and the need for additional treatment.
Potential to Reduce Steroid Exposure
Long-term corticosteroid use can be an important consideration in PMR management. Although steroids can effectively control symptoms, clinicians may need to manage treatment duration and dosing carefully, particularly in patients requiring prolonged therapy.
The proposed Cosentyx indication is specifically focused on adults with inadequate response to steroids or those who relapse during steroid tapering. This population represents patients for whom the existing treatment approach may not provide sufficient or durable disease control.
A targeted treatment option could potentially help physicians manage disease activity while addressing the need to reduce prolonged steroid exposure.
The positive CHMP opinion does not itself constitute final marketing authorization. Instead, it represents the recommendation of the EMA’s scientific committee responsible for evaluating medicines for human use. The recommendation will now move to the European Commission for a final decision.
Next Step: European Commission Decision
Following the CHMP recommendation, the European Commission is expected to issue a final decision within approximately two months.
If the EC grants marketing authorization, Cosentyx could become available in Europe for adults with PMR who have an inadequate response to steroids or who experience relapse during steroid tapering, subject to the final approved labeling and applicable national requirements.
The potential approval would introduce a new targeted mechanism into the European PMR treatment landscape and provide physicians with another option for patients who face challenges with conventional steroid-based management.
For Novartis, the decision would also represent another milestone for Cosentyx, expanding the medicine’s potential role in inflammatory and autoimmune disease.
A Potential Change in PMR Treatment
The positive CHMP opinion comes at a time when the management of PMR continues to face challenges around relapse prevention, sustained remission and corticosteroid exposure. The REPLENISH Phase III results provide clinical evidence supporting the efficacy of Cosentyx at both 300 mg and 150 mg doses, with all primary and secondary endpoints met through week 52.
The absence of new safety signals in PMR patients further supports the regulatory submission, according to Novartis.
If approved by the European Commission, Cosentyx would become the first IL-17A inhibitor approved in Europe for PMR, offering a targeted treatment option for adults whose disease is inadequately controlled by steroids or who relapse during steroid tapering.
The development could be particularly meaningful for patients who face repeated disease flares or difficulty reducing corticosteroid treatment. By targeting IL-17A and demonstrating sustained remission in the Phase III REPLENISH study, Cosentyx has the potential to broaden the treatment approach for PMR beyond conventional steroid management.
The upcoming European Commission decision will determine whether the medicine can move into routine clinical use for this indication. Until then, the CHMP’s positive recommendation represents a significant regulatory milestone for Novartis and for the development of targeted treatment strategies in polymyalgia rheumatica.
About Cosentyx
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)¹⁰⁻¹².
Cosentyx is also approved for use 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.¹⁰⁻¹⁷
About REPLENISH trial
The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with polymyalgia rheumatica (PMR). Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen.
The primary endpoint of the trial was to assess whether Cosentyx 300mg s.c. plus a 24-week steroid taper is superior to placebo plus a 24-week steroid 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 52.¹⁸
About polymyalgia rheumatica (PMR)
Polymyalgia rheumatica (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.³ Relapses are frequent, affecting up to 40% of patients in the first year.⁵ Long-term steroid use is the current standard of care and carries significant risks, including osteoporosis and diabetes.¹⁹ Beyond physical complications, PMR substantially impairs quality of life through pain, fatigue, restricted mobility, and fear of relapse.⁵˒²⁰˒²¹
About Novartis Immunology
At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with complex, and often overlooked autoimmune and immune-mediated diseases, so they can reclaim their lives. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology.