Novartis has announced that ianalumab has received Breakthrough Therapy designation from the US FDA to treat Sjögren’s disease.
Sjögren’s disease is a progressive autoimmune condition. It is the second most widespread rheumatic autoimmune disease, and its impact on organ function can cause symptoms including fatigue, pain and dryness. The disease also carries an increased risk of developing lymphoma.
Because Sjögren’s disease presents differently in every patient, it is often not recognised or diagnosed correctly: around half of people with Sjögren’s disease are thought to be undiagnosed. According to current estimates, Sjögren’s disease affects around 0.25% of the population. It currently has no approved targeted treatments.
Ianalumab is a monoclonal antibody treatment that depletes B-cells and inhibits their activation and survival via B-cell activating factor receptor (BAFF-R) blockade.
The FDA awarded Fast Track designation to ianalumab in 2016. Breakthrough Therapy designation is intended to accelerate the development and regulatory review of treatments that are thought to have significant potential, including treatments for serious conditions and those that answer unmet medical needs.
The designation follows positive data from various studies, including the phase 3 NEPTUNUS-1 and NEPTUNUS-2 studies. Both studies saw ianalumab improve disease activity and reduce patient burden in patients with Sjögren’s disease. The drug also showed a favourable safety profile, with adverse events and serious adverse events being consistent between treatment and placebo arms.
Novartis aims to submit ianalumab for regulatory approval globally starting from early 2026.
Angelika Jahreis, global head, development, immunology at Novartis, said: “This Breakthrough Therapy designation recognises the potential for ianalumab to substantially improve the standard of care for people with Sjögren’s disease, who currently don’t have effective treatment options for this debilitating disease.”