Novartis’ Ianalumab Secures FDA Breakthrough Therapy Status for Sjögren’s disease
Novartis has reported that the US Food and Drug Administration (FDA) has awarded Breakthrough Therapy designation to ianalumab for the treatment of Sjögren’s disease, one of the most prevalent autoimmune rheumatic disorders.
Ianalumab is a fully human monoclonal antibody designed with a dual mode of action. It selectively targets B cells by both reducing their numbers and preventing their activation and survival through inhibition of the B-cell activating factor (BAFF) receptor.
The FDA’s Breakthrough Therapy designation is granted to investigational medicines for serious or life-threatening conditions when preliminary clinical data indicate substantial improvement compared with existing therapies.
The designation is supported by encouraging data from multiple clinical studies, including the Phase III NEPTUNUS-1 and NEPTUNUS-2 trials.
In these studies, ianalumab demonstrated significant reductions in disease activity and patient-reported burden, while showing a safety profile comparable to placebo.
Sjögren’s disease is a long-term, progressive autoimmune condition that can affect several organs. Common symptoms include dry eyes and mouth, fatigue, and chronic pain, and patients also face an elevated risk of developing lymphoma.
The disease affects an estimated 0.25% of the global population, with many cases remaining undiagnosed. At present, no targeted therapies have been approved specifically for Sjögren’s disease.
