Novartis AG (NYSE:NVS) on Wednesday shared topline data from the Phase 3 REPLENISH trial of Cosentyx in patients with polymyalgia rheumatica.
- NVS is trading near recent highs. Track the action here
Polymyalgia rheumatica is the second most common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck, and hips.
Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen.
Also Read: Novartis Cancer Drug Shows Sustained Benefit In Five-Year Breast Cancer Trial
Data
The trial's primary endpoint was whether secukinumab 300mg plus a 24-week steroid taper is superior to placebo plus a 24-week steroid taper in achieving sustained remission at Week 52.
Key secondary endpoints include 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.
The trial met the primary endpoint and all secondary endpoints. Cosentyx demonstrated statistically significant and clinically meaningful sustained remission vs placebo.
A key secondary endpoint of the REPLENISH trial was adjusted annual cumulative steroid dose through Week 52.
Other secondary measures included complete sustained remission at Week 52 and the time until patients needed additional treatment.
Data will be presented at an upcoming medical congress and submitted to health authorities in the first half of 2026.
What Next?
In September, Novartis announced its plans to launch a direct-to-patient (DTP) platform in the U.S., effective November 1, 2025, offering cash-paying patients prescribed Cosentyx (secukinumab) the option to purchase it at a 55% discount off the list price.
Cosentyx, Novartis' top-selling product in the U.S., is an FDA-approved biologic for multiple immune-mediated inflammatory diseases, including psoriasis, hidradenitis suppurativa, and psoriatic arthritis.
Through the DTP platform, Novartis will offer Cosentyx to American patients at a price that reflects the average savings that insurers and pharmacy benefit managers receive.
Price Action: Novartis shares were up 0.34% at $131.78 at the time of publication on Wednesday. The stock is trading near its 52-week high of $133.55, according to Benzinga Pro data.
Read Next:
Photo via Shutterstock
