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Biotech Daily Dose

Johnson & Johnson's IMAAVY Shows Two Years Of GMG Control

By RTTNews Staff Writer   ✉   | Published:   | Follow Us On Google News

Johnson & Johnson (JNJ) has reported long-term data showing IMAAVY (Nipocalimab) maintained disease control for more than two years in adults with generalized myasthenia gravis, reinforcing its potential as a durable treatment option.

Generalised myasthenia gravis (gMG) is a chronic autoimmune condition where antibodies disrupt communication between nerves and muscles, leading to weakness, difficulties in speech swallowing, and mobility. Sustained disease control is a critical goal, as it reduces flare-ups and helps maintain daily function.

The Phase 3 Vivacity-MG3 study, followed by an open-label extension, tracked patients for up to 120 weeks. Results showed consistent improvements in muscle strength and daily living scores, with nearly one-third of patients achieving sustained minimal symptom expression (MSE)- a state where symptoms have little day-to-day impact.

Importantly, corticosteroid use was reduced in more than half of participants, and no unexpected safety concerns emerged. The most common side effects included muscle spasms, peripheral swelling, and changes in lipid levels.

A post-hoc analysis highlighted that patients who reached sustained MSE experienced greater improvements in quality of life compared to those with transient or no MSE. This patient-centric outcome underscores the therapy's potential to deliver meaningful, lasting relief.

Nipocalimab works by blocking the neonatal Fc receptor (FcRn), lowering harmful lgG antibodies while preserving essential immune functions. It is already approved in the European Union as an add-on therapy for antibody-positive gMG patients aged 12 and older. Beyond gMG, the drug is being studied in other autoimmune and maternal-fetal conditions, with several regulatory designations including FDA Fast Track and Breakthrough Therapy status.

The new findings, presented at the American Academy of Neurology 2026 Meeting, mark one of the longest follow-up periods reported for a FcRn blocker in gMG. Johnson & Johnson emphasized that these results strengthen the evidence base for Nipocalimab and highlight its role in reshaping long-term treatment strategies for patients living with this debilitating disease.

JNJ has traded between $146.12 and $251.71 over the past year. The stock closed Thursday's trading at $230.65, up 2.01%. During overnight trading, the stock is at $230.25.

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