USFDA grants Breakthrough Therapy Designation to Nipocalimab for treatment of adults with moderate-to-severe Sjögren's disease: JnJ

The BTD is supported by data from the Phase 2 DAHLIAS study evaluating the efficacy and safety of nipocalimab for the treatment of adult patients with moderate-to-severe SjD and supports further evaluation of the investigational treatment through a Phase 3 study, which is underway. Data from the nipocalimab Phase 2 DAHLIAS study were featured in a late-breaking oral presentation (LBA0010) at the European Alliance of Associations for Rheumatology (EULAR) 2024 Congress and demonstrated the first-ever positive results of an investigational FcRn blocker as a potential targeted therapy in SjD.

The FDA grants BTD to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition and is based on preliminary clinical evidence that indicates the drug may have substantial improvement in at least one clinically significant endpoint over available therapy. Many patients living with SjD experience symptoms that interfere with daily activities and quality of life. While SjD most frequently affects the glands that produce saliva and tears, more systemic symptoms called extraglandular manifestations are common and may impact multiple organ systems, including joints, lungs, kidneys, and nervous system. Patients with SjD also have a high-risk of developing numerous associated conditions, including up to 20 times higher risk of developing B-cell lymphomas when compared to the general population. Patients with high activity in more than one organ or disease domain have an increased mortality risk of up to five-fold.

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