Novartis gets EU nod for Cosentyx in PMR

Novartis (NVS) has gained European Commission approval for 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 decision, Cosentyx becomes the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for adults with PMR.

The new indication targets a defined patient group that does not achieve sufficient control with standard steroid therapy or cannot maintain response while tapering. Regulatory reviews for this PMR use of Cosentyx remain ongoing in the US and Japan.

The approval is supported by data from the Phase III REPLENISH trial. In this study, Cosentyx, in combination with a steroid taper regimen, doubled sustained remission rates versus placebo at Week 52. Patients in the trial were randomized to Cosentyx 300 mg, Cosentyx 150 mg, or placebo, all given alongside a 24-week glucocorticoid taper.

For adults with PMR, the recommended Cosentyx dose is 150 mg administered by subcutaneous injection. Initial dosing is scheduled at Weeks 0, 1, 2, 3, and 4, followed by monthly maintenance dosing. The therapy is used together with a tapering course of glucocorticoids, after which Cosentyx can be continued as monotherapy.

Key secondary endpoints in the trial included the proportion of patients achieving complete sustained remission at Week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through Week 52.

PMR is a common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck, and hips. The condition is particularly prevalent among people of Northern European descent and is associated with a considerable burden of symptoms.

Relapses in PMR are frequent, affecting up to 40% of patients in the first year. Long-term glucocorticoid use is the current standard of care and carries significant risks, including osteoporosis and diabetes. Advanced treatment options have remained limited, and prolonged steroid use has been associated with high relapse rates and adverse outcomes.

Cosentyx is a fully human biologic that directly inhibits IL-17A, a cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It already holds approvals in several adult and pediatric indications, and the new PMR approval in Europe adds another immune-mediated inflammatory disease to its label.