Johnson & Johnson’s (J&J) nipocalimab, a potential immunoselective investigational treatment for adults with systemic lupus erythematosus (lupus), has been granted US FDA Fast Track designation.
The US FDA Fast Track designation programme aims to deliver therapeutics to patients more quickly where unmet needs remain by expediting the development and reviewing timelines of drugs that demonstrate the potential to treat serious conditions.
Lupus is an autoimmune disease disease that affects multiple organs including the skin, joints, kidneys, blood and central nervous systems. Estimated to impact between three and five million people worldwide, lupus can significantly reduce quality of life. Associated chronic signs and symptoms include severe fatigue, pain, swelling and rashes. Systemic inflammation, disease flares and reliance on steroids can cause patients to be at risk of irreversible organ damage.
Leonard Dragone, Disease Area Leader, Autoantibody and Rheumatology at J&J, said: “Nipocalimab earning its fifth FDA Fast Track designation, now in systemic lupus erythematosus, reflects the importance of accelerating the delivery of an immunoselective therapy that could fill an unmet need in this serious condition.”
Nipocalimab lowers immunolobin G (IgG), one of the root causes of autoimmune diseases, while preserving critical immune function.
“This is an important step in our efforts to help address the ongoing burden faced by people living with this debilitating disease. Through close collaboration with the FDA, we seek to advance the development of nipocalimab as a potential new treatment option for the SLE patient community,” Dragone added.
J&J has started enrolling adults with active SLE in the phase 3 GARDENIA study, after reporting positive results from the phase 2b JASMINE trial, where nipocalimab demonstrated a reduction in disease activity.
Richard Furie, Chief of the Division of Rheumatology at Northwell Health, said: “Systemic lupus erythematosus is a serious, complex disease that affects many aspects of a patient’s life, and treatment options remain limited.
“Progress like this brings renewed hope for more targeted therapies and meaningful outcomes for people living with this devastating disease.”