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Johnson & Johnson Says US FDA Grants Fast Track Designation for Sjogren's Disease Treatment
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Johnson & Johnson Says US FDA Grants Fast Track Designation for Sjogren's Disease Treatment
Mar 18, 2025 5:56 AM

08:41 AM EDT, 03/18/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Tuesday that investigational nipocalimab has received fast track designation from the US Food and Drug Administration for the treatment of adult patients with moderate to severe Sjogren's disease.

This comes after the investigational therapy was granted breakthrough therapy designation late last year, the company said.

The company said its mid-stage study from last year showed a greater than 70% relative average improvement in systemic disease activity at the 24th week when compared to placebo and IgG reductions of more than 77%.

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