By Fineline Cube 
US giant Johnson & Johnson (J&J, NYSE: JNJ) unveiled a market approval in the United States for its Imaavy (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody (mAb). The US FDA gave the nod for the drug to be used as a treatment for generalized myasthenia gravis (gMG) in adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.
Understanding gMG and Imaavy’s Mechanism
Generalized myasthenia gravis (gMG) is a chronic, autoimmune disorder with significant unmet needs for therapies offering sustained disease control and proven safety profiles. Anti-AChR/MuSK antibodies are present in ≥90% of antibody-positive gMG patients. Imaavy selectively reduces pathogenic IgG autoantibodies without broadly suppressing adaptive or innate immunity, making it a targeted treatment option.
Clinical Trial Results
The approval is based on the pivotal Vivacity-MG3 trial, where Imaavy in combination with the standard of care (SOC) demonstrated superior 24-week disease control compared to placebo + SOC, measured by MG-ADL score improvement. Sustained efficacy was observed through 20 months in the open-label extension study, with rapid and durable autoantibody reduction (up to 75%) from the first dose. Safety data from Vivacity-MG3 and Vibrance-MG showed consistent tolerability in both adults and adolescents.
Launch and Support Program
J&J will launch the Imaavy WithMe support program in the US, offering commercially insured patients access to $0 co-pay infusions and treatment initiation within one week of prescription. This initiative aims to enhance patient access and support for those living with gMG.-Fineline Info & Tech