Novartis AG (NYSE: NVS) announced that the European Commission (EC) has approved Cosentyx (secukinumab) for the treatment of adults with polymyalgia rheumatica (PMR) who have had an inadequate response to glucocorticoids or who experience relapse during glucocorticoid taper. With this approval, Cosentyx becomes the first and only interleukin‑17A (IL‑17A) inhibitor approved in Europe for adults with PMR – addressing a disease whose standard of care has long been defined by prolonged steroid use and its associated relapse burden.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | European Commission (EU) |
| Approval Type | New indication |
| Product | Cosentyx (secukinumab) – fully human IL‑17A inhibitor |
| Indication | Adults with polymyalgia rheumatica (PMR) with inadequate response to glucocorticoids or relapse during glucocorticoid taper |
| Approval Date | 21 Oct 2026 |
| Distinction | First and only IL‑17A inhibitor approved in Europe for adult PMR |
| Pivotal Trial | Phase III REPLENISH (NCT05767034) |
| Previously Approved Indications | Psoriatic arthritis (PsA), moderate‑to‑severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non‑radiographic axial spondyloarthritis (nr‑axSpA), hidradenitis suppurativa (HS) |
Disease Profile – Polymyalgia Rheumatica
- Definition: A common inflammatory rheumatic disease in adults aged over 50, characterized by acute pain and stiffness in the shoulders, neck, and hips.
- Epidemiology: Particularly prevalent among people of Northern European descent.
- Current Standard of Care: Prolonged steroid use, associated with high relapse rates and significant adverse outcomes.
- Unmet Need: Relapses affect up to 40% of patients within the first year, leaving a large population dependent on glucocorticoids with no approved steroid‑sparing biologic alternative – until now.
Drug Profile & Mechanism of Action
- Molecule: Cosentyx (secukinumab), a fully human biologic.
- Target: Direct inhibition of interleukin‑17A (IL‑17A), a key pro‑inflammatory cytokine implicated in immune‑mediated inflammatory diseases.
- Established Portfolio: Already approved across PsA, PsO, AS, nr‑axSpA, and HS, making PMR the sixth major inflammatory indication for the franchise in Europe.
- Clinical Positioning: Offers a non‑steroid biologic mechanism for glucocorticoid‑inadequate‑response or relapsing PMR, supporting steroid‑sparing treatment strategies.
Clinical Evidence – Phase III REPLENISH Trial (NCT05767034)
| Item | Detail |
|---|---|
| Design | Global, multicenter, randomized, double‑blind, placebo‑controlled, parallel‑group |
| Geography | 27 countries |
| Randomization | 1:1:1 – Cosentyx 300 mg / Cosentyx 150 mg / placebo |
| Background Regimen | All arms received a 24‑week steroid taper regimen |
| Primary Time Point | Week 52 |
| Efficacy Result | Cosentyx doubled sustained remission rates versus placebo (absolute rates not disclosed in the announcement) |
| Safety | Consistent with the established Cosentyx safety profile |
The REPLENISH trial is a global, multicenter, randomized, double‑blind, placebo‑controlled, parallel‑group study conducted across 27 countries. Patients were randomized 1:1:1 to Cosentyx 300 mg, Cosentyx 150 mg, or placebo, all in combination with a 24‑week steroid taper regimen. At Week 52, Cosentyx doubled sustained remission rates versus placebo, with safety results consistent with the established Cosentyx profile – evidence supporting a steroid‑sparing role for IL‑17A inhibition in PMR.
Market Impact & Outlook
- First‑in‑Class Position: As the first and only IL‑17A inhibitor approved for adult PMR in Europe, Cosentyx enters a space with no previously approved biologic, capturing the entire glucocorticoid‑failure population as addressable demand.
- Steroid‑Sparing Value: With up to 40% of patients relapsing within the first year on steroids, a therapy that doubles sustained remission while enabling taper addresses both clinical outcomes and the long‑term toxicity burden of glucocorticoids.
- Franchise Extension: PMR adds a sixth European indication to Cosentyx’s immunology portfolio (PsA, PsO, AS, nr‑axSpA, HS), extending the asset’s lifecycle and revenue base beyond dermatology and axial disease.
- Global Evidence Base: The 27‑country REPLENISH program provides a broad multinational dataset that may support regulatory filings in additional regions; other jurisdictional timelines were not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Cosentyx’s PMR approval, clinical benefits observed in the REPLENISH trial, and commercial potential in the glucocorticoid‑inadequate‑response and relapsing PMR population. Actual results may differ materially due to risks including reimbursement and pricing decisions across EU member states, real‑world clinical experience, competitive therapies, and further regulatory actions.-Fineline Info & Tech
