Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Core Viewpoint - Novartis has received Breakthrough Therapy designation from the FDA for ianalumab, a treatment for Sjögren's disease, which currently lacks effective treatment options [1][2][6] Group 1: Product Information - Ianalumab is a fully human monoclonal antibody that depletes B-cells and inhibits their activation and survival through BAFF-R blockade [1] - The drug is expected to be the first targeted treatment for Sjögren's disease if approved [6] - Novartis plans to submit ianalumab for global regulatory approval starting in early 2026 [1][6] Group 2: Clinical Evidence - The Breakthrough Therapy designation is based on positive data from multiple studies, including phase III trials NEPTUNUS-1 and NEPTUNUS-2, which demonstrated clinically meaningful benefits [2][4] - Ianalumab showed improvement in disease activity and a favorable safety profile, with adverse events comparable to placebo [4] Group 3: Disease Context - Sjögren's disease affects approximately 0.25% of the population, with an estimated 50% of cases remaining undiagnosed [3] - The disease is characterized by symptoms such as dryness, fatigue, and pain, and carries an increased risk of lymphoma [3]