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# J&J Gets Fast Track for Sjögren’s Drug
- URL: https://www.fdaweb.com/j-j-gets-fast-track-for-sjogrens-drug/
- Published: 2025-03-18T12:00:00.000Z
- Updated: 2026-09-14T14:55:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158847

FDA has granted Johnson & Johnson a fast track designation for its investigational therapy, nipocalimab and its use for treating adult patients with moderate-to-severe Sjögren’s disease (SjD). This follows the agency’s breakthrough therapy designation late last year for the therapy.

Sjögren’s disease is a chronic autoimmune disorder that affects moisture-producing glands and can lead to systemic complications such as joint pain, fatigue, and multi-organ inflammation, according to the company. Despite its severity and the associated increased risk of B-cell lymphoma, no FDA-approved therapies currently address the underlying causes of the disease.

Nipocalimab’s potential efficacy was demonstrated in the Phase 2 DAHLIAS study that showed the first-ever positive results of an investigational FcRn blocker as a targeted therapy for SjD, J&J says. The trial achieved its primary endpoint in the 15 mg/kg dosage group, showing over a 70% relative improvement in systemic disease activity at 24 weeks compared to placebo, according to the company. Secondary endpoints also indicated similar improvement trends, with safety and tolerability consistent with other nipocalimab studies, it says.