Europe approves Cosentyx for polymyalgia rheumatica after 41.2% achieve sustained remission in trial

Key Facts

Novartis announced that the European Commission had approved Cosentyx to treat polymyalgia rheumatica, expanding the indications for an existing drug in the company's portfolio. The decision covers adult patients who have had an inadequate response to glucocorticoid treatment, according to the company's approval announcement. It also covers those who relapsed while gradually tapering these drugs, defining the target population for the new treatment for the disease. The decision followed Novartis' announcement on 18 September 2026 that the drug had received a positive recommendation from the Committee for Medicinal Products for Human Use. The approval comes amid a treatment need related to controlling symptoms and reducing relapses, as outlined by researcher Christian Dejaco when the clinical results were announced.

Cosentyx is a fully human biologic that directly inhibits interleukin-17A, according to Novartis' description of its mechanism of action. Polymyalgia rheumatica is characterised by severe pain and stiffness affecting the shoulders, neck and hips, according to the company's trial announcement. Britain's National Health Service says most patients need a course of steroids to prevent symptoms from returning. This treatment usually lasts between 12 months and 2 years, according to the NHS, making symptom management a prolonged process. Long-term steroid treatment carries risks including osteoporosis and diabetes, Novartis said in its announcement of the European regulatory recommendation.

The drug was tested in the REPLENISH trial, conducted in 27 countries, according to Novartis, using a multicentre, parallel-group design. The randomised, double-blind, placebo-controlled study compared 2 Cosentyx treatment groups with a placebo group. All groups received a steroid tapering regimen over 24 weeks alongside their assigned treatment. Sustained remission was achieved by 41.2% of patients in the higher-dose Cosentyx group, according to results announced by the company. The lower-dose group recorded a rate of 40.6%, compared with 20.4% among those receiving placebo. Sustained remission rates in both drug groups were therefore about twice the rate in the comparator group, with all groups following the steroid tapering regimen.

For steroid use during follow-up, the adjusted mean annual cumulative glucocorticoid dose was 1604 mg in the higher-dose Cosentyx group. The mean in the lower-dose group was 1683 mg, according to the trial results table published by Novartis. The placebo group, by comparison, recorded an adjusted mean annual cumulative dose of 2093 mg. By this annual measure, steroid use was lower in both Cosentyx groups than in the placebo group during the trial's year of follow-up. On safety among participating patients with polymyalgia rheumatica, the company said in its regulatory recommendation announcement: "No new safety signals were observed."

Disease recurrence during treatment forms part of the clinical backdrop to this expansion, with Novartis describing relapses as frequent among people with polymyalgia rheumatica. In its trial results announcement, the company said these relapses could affect up to 40% of patients within the first year. Researcher Christian Dejaco pointed to an unmet treatment need among patients who need to keep symptoms under control over time. He described the need as a treatment that "keeps symptoms under control over time with fewer relapses", according to his remarks in the company statement. This need relates to the population covered by the European approval, which allows the drug's use when the response to steroids is inadequate or the disease returns during tapering.

Commercially, Cosentyx sales totalled $1,824 million in the second quarter of the current fiscal year, according to Novartis' earnings announcement for the period. Sales of the drug rose 10% year on year at constant currencies, the company said. Novartis attributed the growth to its performance in the United States, including increased use in hidradenitis suppurativa and of the intravenous formulation. The European approval adds treatment of polymyalgia rheumatica in the specified adult population to the indications for this established revenue-generating drug. On the next regulatory steps, Novartis said in its approval announcement that reviews of Cosentyx for the disease remain underway in other markets, including the United States and Japan.