Novartis announced on October 21, 2026, that the European Commission approved Cosentyx for adults with polymyalgia rheumatica who respond inadequately to glucocorticoids or relapse while reducing their dose. The Cosentyx approval adds a new indication for the company’s immunology medicine and makes it the first interleukin-17A inhibitor authorized in Europe for this condition.
Key Takeaways
- The authorization covers adults with an inadequate glucocorticoid response or relapse during tapering.
- Novartis said the Phase III REPLENISH trial showed doubled sustained remission rates versus placebo at Week 52.
- Regulatory reviews for the PMR indication remain ongoing in the United States and Japan.
Table of Contents
- Cosentyx approval targets a defined PMR patient group
- REPLENISH results supported the authorization
- A broader indication, with other reviews still pending
- Conclusion
Cosentyx approval targets a defined PMR patient group
Novartis’s European Commission approval announcement specifies that Cosentyx, also known as secukinumab, is intended for adults whose disease is not adequately controlled by glucocorticoids or returns as those medicines are tapered. Its first-in-class status applies specifically to IL-17A inhibitors for PMR in Europe, not to all treatments for the disease.
PMR is an inflammatory rheumatic disease affecting older adults, typically causing pain and stiffness in the shoulders, neck and hips. Prolonged steroid treatment is the current standard of care, but relapses and risks associated with long-term use, including osteoporosis and diabetes, create a need for additional options.
The approved regimen combines Cosentyx with a tapering course of glucocorticoids. Cosentyx can then continue as monotherapy after the steroid course ends.
| Item | Details |
|---|---|
| Initial PMR dosing | 150 mg by subcutaneous injection at Weeks 0, 1, 2, 3 and 4. |
| Maintenance dosing | 150 mg monthly after the initial dosing period. |
| Dose adjustment | Maintenance dosing can increase to 300 mg based on clinical response. |
REPLENISH results supported the authorization
The approval was supported by REPLENISH, a global Phase III randomized, double-blind, placebo-controlled study conducted across 27 countries. Participants received Cosentyx at either 300 mg or 150 mg, or placebo, alongside a 24-week steroid taper.
The trial’s primary endpoint compared sustained remission at Week 52 for the 300 mg Cosentyx group against placebo. Novartis said Cosentyx doubled sustained remission rates versus placebo and that safety findings were consistent with the medicine’s established profile.
The study also assessed complete sustained remission, cumulative steroid exposure and the time until patients first needed escape or rescue treatment. These measures address both disease control and reliance on steroids.
A broader indication, with other reviews still pending
The authorization expands the uses of an established Novartis medicine rather than introducing a new drug. Cosentyx already has approvals across several immune-mediated inflammatory diseases, including plaque psoriasis, psoriatic arthritis and hidradenitis suppurativa.
The PMR decision broadens its eligible patient population in Europe. It does not establish future sales or earnings, and the announcement did not quantify the revenue contribution expected from the new indication.
Conclusion
The European decision adds PMR to Cosentyx’s approved uses for a defined group of adults. The next regulatory developments to watch are the ongoing reviews in the United States and Japan; Novartis did not provide decision dates.
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