Novartis AG (NYSE: NVS) 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) in polymyalgia rheumatica (PMR). The opinion supports use of Cosentyx for the treatment of PMR in adults who have had an inadequate response to steroids or who experience relapse during steroid taper.
Regulatory Milestone
| Item | Detail |
|---|---|
| Agency | EMA (European Union) – CHMP |
| Opinion Type | Positive opinion recommending marketing authorization |
| Product | Cosentyx (secukinumab), subcutaneous biologic |
| Indication | Treatment of PMR in adults with inadequate response to steroids or relapse during steroid taper |
| Opinion Date | 18 September 2026 |
| Next Steps | CHMP opinion to be forwarded to the European Commission, which typically issues a final EU‑wide decision within approximately two months |
Drug Profile & Mechanism of Action
- Molecule: Cosentyx (secukinumab), a fully human biologic that directly inhibits interleukin‑17A (IL‑17A), a key pro‑inflammatory cytokine.
- Established Indications: Already approved for psoriatic arthritis (PsA), moderate‑to‑severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non‑radiographic axial spondyloarthritis (nr‑axSpA), and hidradenitis suppurativa (HS).
- Dosing Studied in PMR: Both 300 mg and 150 mg treatment arms were evaluated in the pivotal program.
- Clinical Rationale: PMR is currently managed largely with prolonged corticosteroid courses; a steroid‑sparing biologic addresses the high relapse burden during tapering and the toxicity of chronic steroid exposure, particularly in the older patient population typical of PMR.
- Portfolio Significance: A positive CHMP opinion would extend one of Novartis’ flagship immunology brands into a new rheumatologic indication.
Clinical Evidence – REPLENISH Phase III Trial
| Endpoint | Result (Cosentyx 300 mg & 150 mg) | Relative Assessment |
|---|---|---|
| Primary Endpoint(s) | All met across both dose arms | Supports labeling |
| Complete Sustained Remission | Met | Efficacy demonstrated |
| Time Until Additional Treatment Needed (through Week 52) | Met | Durability of response |
| Safety | No new safety signals identified in PMR patients | Consistent with known profile |
The pivotal REPLENISH Phase III trial met all primary and secondary endpoints across both the 300 mg and 150 mg treatment arms, including complete sustained remission and time until patients needed additional treatment through week 52. Specific endpoint values, sample size, and statistical margins were not disclosed in the announcement.
Market Impact & Outlook
- Unmet Need in PMR: Polymyalgia rheumatica predominantly affects older adults and is treated with extended corticosteroid regimens; frequent relapse during taper drives demand for steroid‑sparing biologic options.
- Competitive Landscape: The IL‑6 inhibitor Kevzara (sarilumab) — Regeneron/Sanofi — is already approved in the US for adults with PMR who have had an inadequate response to corticosteroids, setting up a head‑to‑head rivalry in the emerging biologic PMR segment.
- Franchise Expansion: A PMR authorization would add a sixth major indication to the Cosentyx label, deepening Novartis’ immunology footprint and extending the brand’s lifecycle as its core patents mature.
- Regulatory Momentum: Following the CHMP opinion, the European Commission decision is the final step for EU‑wide authorization; US filing plans were not disclosed.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, including the anticipated European Commission decision, clinical outcomes, and commercial expectations for Cosentyx in polymyalgia rheumatica. Actual results may differ due to risks including final authorization conditions, label scope, payer reimbursement, competitive dynamics, and real‑world adoption.-Fineline Info & Tech
