Novartis has received US Food and Drug Administration Breakthrough Therapy designation for ianalumab as a treatment for Sjögren’s disease. The designation is based on clinical evidence from late-stage trials and is intended to accelerate regulatory review.
FDA designation supports accelerated development
The Breakthrough Therapy designation is granted to therapies intended to treat serious conditions where preliminary clinical evidence suggests improvement over available options. In this case, the decision was supported by data from multiple studies, including replicate Phase III trials.
Ianalumab previously received FDA Fast Track designation in 2016. The latest regulatory milestone reflects continued progress in the programme as Novartis prepares global regulatory submissions.
Ianalumab targets B-cell pathways in autoimmune disease
Ianalumab is a fully human monoclonal antibody with a dual mechanism of action. It depletes B cells and inhibits their activation and survival through blockade of the B-cell activating factor receptor (BAFF-R).
The therapy is being developed for Sjögren’s disease, a chronic autoimmune condition characterised by immune-mediated damage to exocrine glands and systemic involvement.
Sjögren’s disease remains an area of unmet clinical need
Sjögren’s disease is the second most prevalent rheumatic autoimmune disorder and is often underdiagnosed due to its heterogeneous presentation. Symptoms may include dryness, fatigue, pain and an increased risk of lymphoma.
There are currently no approved targeted treatments for Sjögren’s disease. Novartis has stated that it plans to submit ianalumab for regulatory approval globally starting in early 2026.
Further information is available on the Novartis website. Related coverage can be found in the Life Sciences Global News Pharmaceuticals section.
