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Johnson & Johnson Says Nipocalimab Granted FDA Priority Review in Myasthenia Gravis
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Johnson & Johnson Says Nipocalimab Granted FDA Priority Review in Myasthenia Gravis
Jan 9, 2025 6:01 AM

08:44 AM EST, 01/09/2025 (MT Newswires) -- Johnson & Johnson ( JNJ ) said Thursday that the US Food and Drug Administration has granted priority review designation to its biologics license application for nipocalimab to treat antibody positive patients with generalized myasthenia gravis.

The company said its application was supported by the results of a phase 3 study, which showed sustained disease control over 24 weeks in antibody positive adults.

Nipocalimab was also recently granted FDA breakthrough therapy designation in moderate-to-severe Sjogren's disease, the company added.

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