Novartis has secured European Commission approval for Cosentyx (secukinumab) to treat adults with polymyalgia rheumatica (PMR) who have an inadequate response to glucocorticoids or experience a relapse while tapering their steroid treatment.

 

This marks a new milestone in the management of the inflammatory disease.

 

With the approval, Cosentyx becomes the first and only interleukin-17A (IL-17A) inhibitor approved in Europe for adults with PMR, a condition for which treatment options have remained limited despite the significant burden on patients.¹

 

PMR is a common inflammatory rheumatic disease affecting adults over 50. It causes acute pain and stiffness in the shoulders, neck and hips and is particularly prevalent among people of Northern European descent.

 

For patients, managing the disease can mean prolonged steroid treatment, often accompanied by high relapse rates and significant adverse outcomes. Despite the considerable impact on quality of life, advanced treatment options have remained limited.

 

“The approval of secukinumab marks an important advancement for people living with PMR and has the potential to transform how we manage this disease beyond prolonged steroid use alone,” said Prof Christian Dejaco, Director, Department of Rheumatology, South Tyrol Health Trust, Bruneck, Italy. 

 

“Its ability to help patients achieve sustained disease control while tapering steroids, together with its established safety profile, may help address a longstanding challenge in PMR care.”

 

The European approval is supported by data from the Phase III REPLENISH trial. The recommended dose for adults with PMR is 150 mg administered by subcutaneous injection at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance doses alongside a tapering course of glucocorticoids. Cosentyx can then be continued as monotherapy. Depending on clinical response, the maintenance dose may be increased to 300 mg.

 

“People living with PMR need treatment options that can help deliver lasting disease control, prevent relapses and support better long-term outcomes,” said Patrick Horber, President, International, Novartis. 

 

“The approval of Cosentyx in PMR marks an important step forward for patients who continue to face significant challenges with long-term disease management. This milestone adds to the meaningful progress Cosentyx has already brought to many people living with immune-mediated diseases.”