Novartis Cosentyx PMR has moved closer to a potential European indication for polymyalgia rheumatica after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Cosentyx (secukinumab).
The recommendation covers adults with polymyalgia rheumatica (PMR) who have had an inadequate response to steroids or who experience a relapse during steroid tapering. If the European Commission grants final approval, Cosentyx would become the first interleukin-17A (IL-17A) inhibitor approved in Europe for PMR, according to Novartis.
The regulatory development is based on results from the Phase III REPLENISH trial, in which both the 300 mg and 150 mg Cosentyx treatment groups met the reported primary and secondary endpoints. The study evaluated sustained remission, complete sustained remission and the time until patients required additional treatment through Week 52. Novartis reported that no new safety signals were identified in PMR patients receiving Cosentyx.
Novartis Cosentyx PMR Recommendation Follows Phase III REPLENISH Results
The REPLENISH study was a global, randomized, double-blind, placebo-controlled Phase III trial conducted across 27 countries. Patients were assigned to receive Cosentyx 300 mg, Cosentyx 150 mg or placebo, with all groups receiving a 24-week steroid taper regimen.
The primary endpoint assessed whether Cosentyx 300 mg administered subcutaneously alongside a 24-week steroid taper was superior to placebo plus the same steroid taper in achieving sustained remission at Week 52. Secondary endpoints included complete sustained remission, adjusted annual cumulative steroid dose and time to first use of escape or rescue treatment.
REPLENISH Phase III Data for Cosentyx in PMR
| Endpoint at Week 52 | Cosentyx 300 mg | Cosentyx 150 mg | Placebo |
|---|---|---|---|
| Sustained remission | 41.2% | 40.6% | 20.4% |
| Mean adjusted annual cumulative glucocorticoid dose | 1,604 mg | 1,683 mg | 2,093 mg |
| Trial | REPLENISH Phase III | REPLENISH Phase III | REPLENISH Phase III |
| Study population | Adults with PMR | Adults with PMR | Adults with PMR |
The earlier publication of the REPLENISH results reported sustained remission in 41.2% of patients receiving 300 mg Cosentyx and 40.6% receiving 150 mg, compared with 20.4% receiving placebo. The reported mean adjusted annual cumulative glucocorticoid doses were 1,604 mg, 1,683 mg and 2,093 mg, respectively.
What the Novartis Cosentyx PMR Opinion Means for Steroid Use
PMR is an inflammatory rheumatic disease primarily affecting adults aged 50 years and older. Novartis describes the disease as typically involving acute pain and stiffness affecting the shoulders, neck and hips.
The company states that relapses can affect up to 40% of patients during the first year. Corticosteroids remain the current standard of care, while extended steroid exposure is associated with risks including osteoporosis and diabetes.
The REPLENISH findings are therefore particularly relevant to the steroid-sparing component of the proposed Cosentyx indication. The trial evaluated Cosentyx in combination with a defined steroid-taper regimen rather than as a replacement for steroid treatment at the start of therapy. The reported reduction in cumulative glucocorticoid exposure was one of the key secondary outcomes.
Cosentyx Uses IL-17A Inhibition in PMR
Cosentyx is a fully human biologic that directly inhibits interleukin-17A, or IL-17A, a cytokine involved in inflammation underlying multiple immune-mediated inflammatory diseases.
According to Novartis, Cosentyx is already approved for several immune-mediated inflammatory conditions, including psoriatic arthritis, moderate-to-severe plaque psoriasis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa. The medicine also has approved pediatric indications in specified conditions.
The proposed PMR indication would expand the medicine’s use into another inflammatory rheumatic disease. The CHMP recommendation specifically concerns adults whose disease has responded inadequately to steroids or who relapse while steroids are being tapered.
European Commission Decision Expected After CHMP Opinion
A positive CHMP opinion is a recommendation rather than the final European marketing authorization. Novartis said that, following the CHMP recommendation, the European Commission is expected to issue a final decision within approximately two months.
The European regulatory process is therefore the next key step for the proposed PMR indication. The EMA’s publicly available Cosentyx information confirms that Cosentyx is an authorized medicine in the European Union and maintains its assessment history and regulatory documentation.
Novartis Cosentyx PMR Data and the REPLENISH Trial
The REPLENISH trial was registered as NCT05767034 and evaluated subcutaneous secukinumab against placebo in combination with a glucocorticoid taper in patients with PMR. Novartis reported that the trial included participants from 27 countries.
| REPLENISH Trial Data | Details |
|---|---|
| Trial name | REPLENISH |
| Phase | Phase III |
| ClinicalTrials.gov identifier | NCT05767034 |
| Disease | Polymyalgia rheumatica |
| Study design | Randomized, double-blind, placebo-controlled, parallel-group |
| Countries | 27 |
| Treatment arms | Cosentyx 300 mg, Cosentyx 150 mg, placebo |
| Steroid regimen | 24-week steroid taper |
| Primary assessment | Sustained remission at Week 52 |
| Key secondary measures | Complete sustained remission, cumulative glucocorticoid dose, time to escape/rescue treatment |
| Administration | Subcutaneous |
The trial results were published in the New England Journal of Medicine and presented at the 2026 European Alliance of Associations for Rheumatology Congress, according to Novartis.
The original June 2026 Novartis data release reported that the REPLENISH trial met its primary and secondary endpoints across both Cosentyx treatment arms and that no new safety signals were identified in PMR patients.
Safety Findings Remained Consistent With Established Cosentyx Profile
Safety is another component of the regulatory assessment. Novartis reported that no new safety signals were identified among PMR patients receiving Cosentyx and described the safety findings as consistent with the medicine’s established profile.
The September 2026 CHMP development follows the company’s earlier regulatory submissions for the PMR indication in the United States, European Union and Japan. Novartis said additional country filings were expected throughout 2026.
What Happens Next for Cosentyx in PMR?
The immediate regulatory milestone is the European Commission’s decision following the CHMP positive opinion. A final authorization would determine whether the proposed PMR indication becomes available under the European Union marketing authorization.
The development also represents an expansion of the clinical program for secukinumab in immune-mediated inflammatory diseases. For PMR specifically, the REPLENISH results provide the clinical basis cited by Novartis for the proposed indication, with sustained remission and reduced cumulative glucocorticoid exposure among the central findings.
