The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ianalumab for the treatment of Sjogren’s disease, the second most common rheumatic autoimmune disorder. Ianalumab, formulated by Novartis, it is a fully human monoclonal antibody featuring a novel dual mechanism of action that both depletes B cells and inhibits their activation and survival through blockade of the BAFF receptor (BAFF-R).

The Breakthrough Therapy designation is intended to expedite the development and regulatory review of therapies that address serious conditions and significant unmet medical needs. The decision follows earlier FDA Fast Track designation awarded to ianalumab in 2016 and is supported by positive data from multiple studies, including replicate Phase III clinical trials.

Angelika Jahreis, Global Head of Development, Immunology, Novartis, said, “This Breakthrough Therapy designation underscores the potential of ianalumab to meaningfully improve care for people living with Sjogren’s disease, a condition for which effective treatment options remain extremely limited. We look forward to continued collaboration with the FDA as we work toward making this therapy available to patients as quickly as possible.”

Sjogren’s disease is a chronic, progressive autoimmune condition that can affect multiple organs and is associated with symptoms such as severe dryness, fatigue, pain and an elevated risk of lymphoma. The disease’s heterogeneous presentation often leads to delayed or missed diagnosis. It is estimated to affect around 0.25 percent of the population, with nearly half of patients remaining undiagnosed. Currently, there are no approved targeted therapies for the disease.

Novartis plans to begin submitting ianalumab for regulatory approval globally starting in early 2026. If approved, ianalumab would become the first targeted treatment option for patients with Sjögren’s disease, addressing a major unmet need in autoimmune care.