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# J&J’s Nipocalimab Gets Breakthrough Status
- URL: https://www.fdaweb.com/j-js-nipocalimab-gets-breakthrough-status/
- Published: 2024-11-11T12:00:00.000Z
- Updated: 2026-09-14T14:46:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158157

FDA has granted Johnson & Johnson a breakthrough therapy designation for nipocalimab and its use for treating adults living with moderate-to-severe Sjögren's disease (SjD), a debilitating and chronic autoantibody disease. Nipocalimab is said to be the only investigational therapy to win breakthrough status for SjD.

The designation is based on 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,” J&J says. “Data from the nipocalimab Phase 2 DAHLIAS study were [featured](https://c212.net/c/link/?t=0&l=en&o=4299694-1&h=569424045&u=https%3A%2F%2Fwww.jnj.com%2Fmedia-center%2Fpress-releases%2Flate-breaking-results-show-nipocalimab-significantly-improves-sjogrens-disease-activity-in-a-phase-2-study&a=featured&ref=fdaweb.com) 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.”

Monoclonal antibody nipocalimab is designed to “bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies, potentially without impact on other immune functions,” the company says.