J&J: 'Breakthrough Therapy' from the FDA for nipocalimab

(CercleFinance.com) - Johnson & Johnson announces that the FDA has granted nipocalimab Breakthrough Therapy (BTD) designation for the treatment of adults with moderate to severe Sjögren's disease.


Nipocalimab is the first investigational treatment to receive this designation for this disease.

This regulatory milestone, the second for nipocalimab, is based on positive results from the Phase 2 DAHLIAS study, presented at EULAR 2024.

FDA grants BTD to accelerate development of drugs to treat serious conditions.

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