US giant Johnson & Johnson (J&J; NYSE: JNJ) announced receiving Fast Track designation (FTD) from the US FDA for its nipocalimab as a treatment for adult patients with moderate-to-severe Sjögren’s disease (SjD). This designation follows the monoclonal antibody’s Breakthrough Therapy Designation (BTD) received from the agency late last year.
Mechanism of Action
Nipocalimab is a human immunoglobulin G (IgG)1 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) with high specificity and affinity. This mechanism enables the drug to reduce IgG levels in the bloodstream, including pathogenic autoantibodies, by over 75% in some studies.
Significance for Sjögren’s Disease Treatment
Sjögren’s disease is a chronic autoimmune disorder characterized by the infiltration of lymphocytes into exocrine glands, leading to symptoms such as dry eyes and mouth. The condition affects approximately 1 in 1,000 people, with women being nine times more likely to develop the disease than men. Current treatment options are limited, making nipocalimab’s development a significant step forward in addressing this unmet medical need.-Fineline Info & Tech
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