Johnson & Johnson (JNJ), on Thursday, announced that its Biologics License Application for Nipocalimab for the treatment of people living with generalized myasthenia gravis has been accepted for priority review by the FDA.
Nipocalimab is a monoclonal antibody designed to block FcRn (neonatal Fc receptor), thereby reducing levels of immunoglobulin G (IgG) antibodies while maintaining immune function.
Generalized myasthenia gravis is a rare autoimmune disorder affecting around 100,000 people in the U.S., with few treatment options available.
In a phase III clinical trial, Nipocalimab provided sustained disease control for people living with generalized myasthenia gravis, a chronic, life-long disease, according to the company.
The Biologics License Application for Nipocalimab was submitted to the FDA on Aug.29, 2024. While the exact decision date is not specified, it is expected to be announced by the end of April 2025.
If approved, Nipocalimab could offer a targeted treatment option for gMG patients, potentially improving outcomes over current therapies.
JNJ closed Wednesday's (Jan. 08, 2025) trading at $142.27, down 2.71%. In after-hours trading, the stock was down 0.01% at $142.25
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