Swiss pharmaceutical company Novartis AG (SIX: NOVN; NYSE: NVS) on Wednesday said the European Commission has approved Cosentyx (secukinumab) for adults with polymyalgia rheumatica (PMR) who have had an inadequate response to glucocorticoids or who relapse during glucocorticoid tapering.

The approval makes Cosentyx the first and only interleukin-17A inhibitor authorised in Europe for adults with PMR, a common inflammatory rheumatic disease affecting people aged over 50 and currently treated primarily with long-term steroids.

Novartis said the decision was based on data from the Phase III REPLENISH trial, which showed Cosentyx doubled sustained remission rates versus placebo at Week 52, with a safety profile consistent with previous experience of the drug.

Under the approved regimen, Cosentyx is administered by subcutaneous injection alongside a tapering course of glucocorticoids before continuing as monotherapy, with maintenance dosing adjustable according to clinical response.

The REPLENISH study enrolled patients across 27 countries and evaluated Cosentyx 300 mg, Cosentyx 150 mg and placebo, each combined with a 24-week steroid taper programme.

Cosentyx is already approved for several immune-mediated inflammatory diseases, including psoriatic arthritis, plaque psoriasis, ankylosing spondylitis, non-radiographic axial spondyloarthritis and hidradenitis suppurativa. Additional regulatory reviews of Cosentyx for PMR are ongoing in other markets, including the United States and Japan.