Novartis secukinumab gets positive CHMP opinion for PMR
Novartis has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommending marketing authorisation for Cosentyx (secukinumab) in polymyalgia rheumatica (PMR). If confirmed by the European Commission, which is expected to issue a decision within approximately two months, secukinumab would become the first IL-17A inhibitor licensed in Europe for adults with the condition.
The opinion covers patients who have had an inadequate response to corticosteroids or who relapse during a steroid taper, a population for whom treatment options have historically been limited to prolonged steroid use despite its well-documented risks, including osteoporosis and diabetes.
REPLENISH trial data
The CHMP recommendation draws on results from the pivotal Phase III REPLENISH trial (NCT05767034), a global, randomised, double-blind, placebo-controlled study conducted across 27 countries. Both the 300mg and 150mg doses of secukinumab met all primary and key secondary endpoints, including complete sustained remission at week 52 and delayed time to rescue or escape treatment. Novartis reported that the drug doubled sustained remission rates versus placebo and produced a meaningful reduction in cumulative steroid dose. No new safety signals were identified. The full dataset was published in the New England Journal of Medicine and simultaneously presented at the EULAR Congress in June 2026.
Prof Christian Dejaco, Director of Rheumatology at the South Tyrol Health Trust in Bruneck, Italy, said the positive opinion offered clinicians "an effective treatment option while also reducing reliance on steroids, which can present challenges with long-term use."
Market context and competitive landscape
PMR is one of the most common inflammatory rheumatic diseases in adults over 50, with relapse affecting up to 40% of patients in the first year according to published literature. Despite that prevalence, the approved treatment landscape in Europe has remained narrow. Sarilumab, an IL-6 receptor antagonist marketed by Sanofi and Regeneron as Kevzara, holds approval in both the US and EU for PMR, meaning secukinumab would enter as a second advanced-therapy option in the indication rather than the first of any class. The distinction Novartis is emphasising is mechanism: IL-17A inhibition is a different biological pathway to IL-6 blockade, and clinicians treating patients who fail or cannot tolerate sarilumab would have a biologically distinct alternative if the EC confirms the opinion.
Cosentyx is already authorised across a wide range of immune-mediated conditions, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and hidradenitis suppurativa in both adults and paediatric populations. A PMR approval would extend the drug's label into rheumatology's elderly-patient segment, a commercially meaningful step given the age profile of the condition. Payer negotiations across European markets are likely to focus on the steroid-sparing evidence, which aligns with health-technology assessment frameworks that increasingly value reduced long-term medication burden alongside efficacy.
The European Commission's decision, expected by mid-November 2026 if the standard two-month timeline holds, will be the final regulatory gate before Novartis can begin commercial launches across EU member states.