Novartis Wins EMA Approval for Cosentyx in Polymyalgia Rheumatica

Novartis has secured European Medicines Agency (EMA) approval for secukinumab (Cosentyx) in the treatment of polymyalgia rheumatica (PMR), a chronic inflammatory disease that predominantly affects adults over the age of 50 and has, until now, been managed almost exclusively with long-term corticosteroid therapy.

The approval marks a watershed moment in rheumatology. For more than half a century, glucocorticoids such as prednisolone have remained the standard of care for PMR, offering symptomatic relief but carrying well-documented risks including osteoporosis, diabetes, cardiovascular complications, and adrenal suppression, risks that are particularly pronounced in the elderly population most affected by the disease.

Clinical Evidence Underpinning the Decision

The EMA's Committee for Medicinal Products for Human Use (CHMP) based its positive opinion on data from the Phase III SEMAPHORE trial, which evaluated secukinumab against placebo in patients with new-onset or relapsing PMR who were receiving background corticosteroid therapy. The trial demonstrated that patients treated with secukinumab achieved significantly higher rates of sustained remission compared with those receiving placebo, while also enabling meaningful reductions in cumulative corticosteroid exposure, a clinically critical endpoint given the steroid-related morbidity burden in this population.

Sustained remission, defined as the absence of disease flare alongside successful corticosteroid tapering to zero or near-zero doses, was achieved in a substantially greater proportion of secukinumab-treated patients. The safety profile observed in SEMAPHORE was consistent with the established profile of secukinumab across its approved indications, with no new safety signals identified.

A Significant Portfolio Expansion for Novartis

The PMR approval adds a strategically important indication to Cosentyx's already extensive label. Since its initial approval in 2015 for plaque psoriasis, secukinumab has accumulated approvals across psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and enthesitis-related arthritis. PMR represents the drug's first approved indication in a disease defined primarily by large-vessel and proximal musculoskeletal inflammation rather than the spondyloarthropathy or psoriatic pathways that characterised earlier expansions.

For Novartis, the commercial implications are considerable. PMR is among the most common inflammatory rheumatic diseases in adults over 50 in Europe, with incidence rates rising sharply with age. Estimates suggest prevalence of approximately 1 in 133 adults over 50 in Northern European populations, translating to a patient pool of several hundred thousand across the EU alone. The majority of these patients are currently managed in primary care or general rheumatology settings with corticosteroids, and a meaningful subset experience relapsing disease requiring prolonged steroid courses.

Addressing an Unmet Need Rooted in Biology

The rationale for targeting IL-17A in PMR has been supported by translational research demonstrating elevated IL-17A expression in temporal artery biopsies and peripheral blood of PMR patients, alongside evidence of dysregulated innate and adaptive immune responses involving Th17 pathways. While IL-6 inhibition with tocilizumab has shown activity in the related condition giant cell arteritis (GCA), the immunological landscape of PMR, which shares some but not all pathological features with GCA, suggested that IL-17A blockade could offer a complementary or distinct mechanism of benefit.

The SEMAPHORE data appear to validate this hypothesis at a clinical level, though rheumatologists will be watching closely for real-world evidence on which patient subgroups derive the greatest benefit, optimal sequencing with corticosteroids, and long-term durability of remission.

Manufacturing and Supply Considerations

Secukinumab is manufactured at Novartis's biologics facilities, with the company having invested substantially in production capacity for the molecule over the past decade in line with its expanding indication set. The PMR approval is not expected to create near-term supply constraints, given existing infrastructure, though commercial teams will need to address the distinct prescriber base for PMR, which skews toward general rheumatologists and, in some markets, primary care physicians, compared with the dermatology and specialist rheumatology networks that have historically driven Cosentyx volumes.

Regulatory and Market Access Pathway

Following the CHMP positive opinion, the European Commission issued formal approval, making the indication valid across all EU member states. National reimbursement decisions will follow on country-specific timelines, with health technology assessment bodies in markets including Germany, France, and the United Kingdom likely to scrutinise the incremental cost-effectiveness of secukinumab relative to continued corticosteroid-based management, a comparator that, while associated with significant long-term morbidity costs, carries a very low acquisition price.

Novartis will need to make a compelling health-economic case centred on steroid-sparing benefits, reduced complication rates, and quality-of-life improvements to secure broad reimbursement. The company is expected to engage HTA bodies with long-term modelling data drawing on both the SEMAPHORE trial and real-world corticosteroid complication registries.

Broader Implications for Inflammatory Disease Treatment

The approval carries significance beyond Novartis's commercial interests. It signals a broader maturation of the biologics landscape in rheumatology, where conditions long considered refractory to targeted therapy, due to their heterogeneous pathology or predominantly elderly patient populations, are increasingly yielding to mechanism-based intervention. For patients who have endured years of steroid-related side effects with limited alternatives, the availability of an approved biologic represents a meaningful clinical advance.

Rheumatology societies across Europe are expected to update clinical guidelines to incorporate secukinumab as a treatment option, likely positioned for patients with relapsing or refractory PMR, those at high risk of steroid-related complications, or those unable to taper corticosteroids successfully. The precise positioning will depend on the granularity of label language and the outcomes of ongoing health-economic evaluations.

For the broader pharmaceutical industry, the PMR approval reinforces the value of pursuing indication expansions in established biologics where mechanistic rationale and unmet need converge, a strategy that continues to generate significant returns for companies willing to invest in late-phase trials in underserved disease areas.