FDA Approves Nipocalimab for the Treatment of Generalized Myasthenia Gravis
Approval is based on results from the pivotal Vivacity-MG3 trial in which IMAAVY (nipocalimab-aahu) demonstrated superior disease control throughout 24 weeks when compared to placebo plus standard of care.
The FDA has approved Johnson & Johnson’s IMAAVY (nipocalimab-aahu) for the treatment of treatment of generalized myasthenia gravis (gMG). Following FDA Priority Review designation, this approval offers a new, effective treatment option for adults and pediatric patients 12 years of age and older with gMG who are anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) antibody positive.1
The approval of IMAAVY is based on results from the pivotal Phase III Vivacity-MG3 clinical trial. The patient population enrolled in the study accounts for approximately 95% of people living with gMG. When receiving nipocalimab plus standard or care (SOC), patients saw an improvement of 4.70 points in MG-ADL score, which is significantly more than the 3.25 point demonstrated by placebo plus SOC.2
In a press release, Samantha Masterson, president and CEO, Myasthenia Gravis Foundation of America, said: “We consistently hear from individuals living with myasthenia gravis who are hopeful for new treatment options that may help bring greater stability, independence and predictability to their lives. Today’s announcement provides another option which could help address the constant uncertainty and heavy physical and mental toll that MG symptom relapse presents to patients and their families.”
Nicholas J. Silvestri, MD, professor of neurology at University of Buffalo, added: “The clinical results we’ve seen with IMAAVY represent a significant milestone in the treatment of gMG. Patients experienced substantial symptom relief and lasting disease control that translated into better daily function and did not fade over 24 weeks in the pivotal Vivacity-MG3 study. Having a treatment that delivers this level of durable symptom stability is a meaningful step forward for managing a complex and unpredictable disease like gMG, and to have it in both AChR+ and MuSK+ adults and pediatric patients 12 years and older brings an additional FcRn treatment to a broader range of patients.”
Johnson & Johnson announced the results of Vivacity-MG3 in June 2024. The trial met its primary endpoint of improvement in MG-ADL score from baseline over 24 weeks. The improvement in MG-ADL observed translates to patients regaining essential daily functions such as chewing, swallowing, speaking, and breathing. Additionally, patients experienced improvements in strength and function of different muscle groups significantly more than those in the placebo plus SOC arm over weeks 22 and 24 of the study.2
In a press release from the time of when the trial results were announced, Carlo Antozzi, MD, neuroimmunology and muscle pathology unit of the Neurological Institute Foundation C. Besta of Milan, Italy, said: “The sustained response of nipocalimab over six months among this broad myasthenia gravis population is an important finding given the chronic, unpredictable exacerbations typically seen with myasthenia gravis. We are encouraged by the potential of nipocalimab to uniquely help address this gap for people living with myasthenia gravis.”
Johnson & Johnson is also evaluating IMAAVY in the Phase II/III Vibrance study. The patient population is comprised of anti-AChR and anti-MuSK antibody positive adolescents, aged 12-17 years. Data show the trial met its primary endpoint with IMAAVY plus SOC demonstrating a 69% reduction in total serum immunoglobulin G over 24 weeks.
David Lee, MD, PhD, global immunology therapeutic area head, Johnson & Johnson Innovative Medicine, said: “Today’s FDA approval of IMAAVY marks a historic milestone for the more than 240 million patients suffering with autoantibody diseases, many with few or no approved targeted treatments. This approval is the result of years of scientific commitment, collaboration and determination for our nipocalimab program, and we’re proud to bring this new treatment option to patients living with anti-AChR or anti-MuSK antibody positive gMG.”
According to Johnson & Johnson, nipocalimab is now the first and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older.
References
1. Johnson & Johnson receives FDA approval for IMAAVYTM (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG). News release. Johnson & Johnson. April 30, 2025. Accessed April 30, 2025. https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-fda-approval-for-imaavytm-nipocalimab-aahu-a-new-fcrn-blocker-offering-long-lasting-disease-control-in-the-broadest-population-of-people-living-with-generalized-myasthenia-gravis-gmg
2. Nipocalimab pivotal Phase 3 trial demonstrates longest sustained disease control in FcRn class. News release. Johnson & Johnson. June 28, 2024. Accessed April 30, 2025. https://www.jnj.com/media-center/press-releases/nipocalimab-pivotal-phase-3-trial-demonstrates-longest-sustained-disease-control-in-fcrn-class
Addressing Disparities in Psoriasis Trials: Takeda's Strategies for Inclusivity in Clinical Research
April 14th 2025LaShell Robinson, Head of Global Feasibility and Trial Equity at Takeda, speaks about the company's strategies to engage patients in underrepresented populations in its phase III psoriasis trials.
Beyond the Prescription: Pharma's Role in Digital Health Conversations
April 1st 2025Join us for an insightful conversation with Jennifer Harakal, Head of Regulatory Affairs at Canopy Life Sciences, as we unpack the evolving intersection of social media and healthcare decisions. Discover how pharmaceutical companies can navigate regulatory challenges while meaningfully engaging with consumers in digital spaces. Jennifer shares expert strategies for responsible marketing, working with influencers, and creating educational content that bridges the gap between patients and healthcare providers. A must-listen for pharma marketers looking to build trust and compliance in today's social media landscape.
