Novartis Secures European Commission’s Approval for Cosentyx®️ in Polymyalgia Rheumatica (PMR)
With this approval, Cosentyx becomes the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for PMR, expanding treatment options for patients with this inflammatory rheumatic disease.
PMR primarily affects adults aged 50 and older, causing pain and stiffness in the shoulders, neck and hips. Although glucocorticoids remain the standard treatment, prolonged use can increase the risk of complications, including osteoporosis and diabetes. Relapses can also complicate long-term disease management.
The approval is supported by findings from the Phase III REPLENISH trial, which evaluated secukinumab alongside a glucocorticoid taper regimen. The study demonstrated that Cosentyx doubled sustained remission rates compared with placebo at Week 52. The reported safety results were consistent with the drug’s established safety profile.
Cosentyx works by inhibiting IL-17A, a cytokine involved in inflammatory processes associated with immune-mediated diseases. For PMR, the approved regimen begins with subcutaneous injections at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing alongside glucocorticoid tapering. Depending on clinical response, the maintenance dose may be increased to 300 mg. After glucocorticoids are discontinued, Cosentyx may be continued as monotherapy.
The European approval adds another indication to Cosentyx’s existing portfolio of immune-mediated inflammatory diseases. Novartis said regulatory reviews for the PMR indication are also ongoing in other markets, including the United States and Japan.
Novartis has received European Commission approval for Cosentyx® (secukinumab) to treat adults with polymyalgia rheumatica (PMR) who respond inadequately to glucocorticoids or experience relapse while tapering steroid treatment.
With this approval, Cosentyx becomes the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for PMR, expanding treatment options for patients with this inflammatory rheumatic disease.
PMR primarily affects adults aged 50 and older, causing pain and stiffness in the shoulders, neck and hips. Although glucocorticoids remain the standard treatment, prolonged use can increase the risk of complications, including osteoporosis and diabetes. Relapses can also complicate long-term disease management.
The approval is supported by findings from the Phase III REPLENISH trial, which evaluated secukinumab alongside a glucocorticoid taper regimen. The study demonstrated that Cosentyx doubled sustained remission rates compared with placebo at Week 52. The reported safety results were consistent with the drug’s established safety profile.
Cosentyx works by inhibiting IL-17A, a cytokine involved in inflammatory processes associated with immune-mediated diseases. For PMR, the approved regimen begins with subcutaneous injections at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing alongside glucocorticoid tapering. Depending on clinical response, the maintenance dose may be increased to 300 mg. After glucocorticoids are discontinued, Cosentyx may be continued as monotherapy.
The European approval adds another indication to Cosentyx’s existing portfolio of immune-mediated inflammatory diseases. Novartis said regulatory reviews for the PMR indication are also ongoing in other markets, including the United States and Japan.
Written by: Pramit Hazra
Graphics by: Pramit Hazra
