Novartis announced that the US FDA has granted Breakthrough Therapy designation to ianalumab for the treatment of Sjögren’s disease. Sjögren’s is the second most prevalent rheumatic autoimmune disease. There are currently no approved targeted treatments available.
Breakthrough Therapy designation is reserved for medicines that show potential to deliver substantial improvement over existing care. For Sjögren’s patients, treatment options are limited and largely symptomatic.
If approved, ianalumab would become the first targeted therapy for this disease.
Ianalumab is a fully human monoclonal antibody with a dual mechanism of action.
It works by: