Johnson & Johnson receives FDA approval for IMAAVY™ (nipocalimab-aahu), a new FcRn blocker offering long-lasting disease control in the broadest population of people living with generalized myasthenia gravis (gMG)

Rhea-AI Summary

Johnson & Johnson has received FDA approval for IMAAVY™ (nipocalimab-aahu), a groundbreaking FcRn blocker for treating generalized myasthenia gravis (gMG). The treatment is approved for both adult and pediatric patients aged 12 and older who are anti-AChR or anti-MuSK antibody positive, covering over 90% of antibody-positive gMG patients.

Key highlights from clinical trials:

• Demonstrated 20 months of lasting disease control and symptom relief
• Reduced harmful IgG autoantibody levels by up to 75% from first dose
• Showed superior disease control over 24 weeks compared to placebo
• Maintained consistent safety profile in both adult and pediatric populations

Through the IMAAVY withMe program, commercially insured U.S. patients may receive their first treatment within one week and could pay as little as $0 per infusion. The approval follows FDA Priority Review designation and represents a significant advancement in gMG treatment options.

Positive

• FDA approval for IMAAVY expands J&J's portfolio in the lucrative autoimmune disease market
• IMAAVY received FDA Priority Review designation, accelerating market entry
• Broadest patient population approval (adults + 12+ years, both anti-AChR and anti-MuSK positive)
• Strong efficacy data showing 75% reduction in autoantibody levels from first dose
• 20 months of sustained disease control demonstrated in clinical trials
• Commercial insurance program 'IMAAVY withMe' offers $0 per infusion, potentially driving adoption
• Global expansion potential with submissions under review worldwide

Negative

• No pricing information disclosed for IMAAVY
• Will face competition in the established FcRn blocker class
• Ongoing costs of patient support program may impact margins

Insights

Pharmaceutical Industry Analyst

FDA approval of J&J's IMAAVY strengthens immunology portfolio with first-in-class gMG treatment addressing significant unmet needs.

The FDA approval of IMAAVY (nipocalimab-aahu) marks a significant milestone for Johnson & Johnson's immunology portfolio. As the first and only FcRn blocker approved for both anti-AChR and anti-MuSK antibody positive generalized myasthenia gravis (gMG) patients, J&J has secured an important position addressing an unmet need affecting ≥90% of antibody-positive gMG patients.

The approval followed FDA Priority Review designation, highlighting the treatment's clinical importance. The drug demonstrated exceptional durability with 20 months of lasting disease control in the ongoing open-label extension of the Vivacity-MG3 study, positioning it as a potentially valuable long-term treatment option.

J&J's strategic patient support program (IMAAVY withMe) offering commercially insured patients first treatment in as quickly as one week with potential $0 per infusion cost reduces access barriers that could otherwise limit initial adoption. The company has already submitted for global regulatory approvals, indicating a comprehensive commercialization strategy.

This approval delivers on J&J's stated mission of addressing autoantibody diseases, which they note affect more than 240 million patients globally, strengthening their competitive position in the growing immunology therapeutic area.

Neurologist

IMAAVY provides durable symptom control for gMG patients through targeted 75% reduction in pathogenic antibodies with excellent safety profile.

The FDA approval of IMAAVY (nipocalimab-aahu) represents a clinically significant advancement in gMG treatment options. The Vivacity-MG3 study demonstrated IMAAVY substantially reduced pathogenic IgG antibodies by up to 75% from first dose throughout the 24-week monitoring period, addressing a fundamental disease mechanism.

What's particularly notable is the durability of response - participants maintained improvements for up to 20 months in the ongoing extension study. For gMG patients, characterized by unpredictable symptom fluctuations, this level of sustained disease control directly translates to regaining essential functions like chewing, swallowing, speaking and breathing.

The broad approval covering both adult and pediatric patients aged 12+ with anti-AChR or anti-MuSK antibody positivity makes this applicable to approximately 90% of antibody-positive gMG patients. This is particularly meaningful for adolescent patients who have historically had fewer treatment options.

IMAAVY's immunoselective mechanism works by reducing harmful autoantibodies without additional detected effects on other immune functions, offering a targeted approach with a consistent safety profile demonstrated across both adult and pediatric populations. This favorable benefit-risk profile should support clinical adoption as physicians seek effective, well-tolerated options for this debilitating autoimmune condition.

First and only FcRn blocker approved in anti-AChR and anti-MuSK antibody positive adults and pediatric gMG patients aged 12 and older  

IMAAVY delivered rapid and substantial reduction in immunoglobulin G (IgG) levels, one of the root causes of gMG, in both the adult and pediatric pivotal studies          

gMG patients taking IMAAVY demonstrated 20 months of lasting disease control and symptom relief in the pivotal Vivacity-MG3 study and ongoing open-label extension (OLE)

SPRING HOUSE, Pa., April 30, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced that the U.S. Food and Drug Administration (FDA) has approved IMAAVY™ (nipocalimab-aahu), a human FcRn-blocking monoclonal antibody, for the treatment of generalized myasthenia gravis (gMG). The approval, which follows FDA Priority Review designation, offers a new treatment option in a proven class with the potential for lasting disease control in the broadest population of people living with gMG (adults and pediatric patients 12 years of age and older who are anti-acetylcholine receptor [AChR] or anti-muscle-specific kinase [MuSK] antibody positive).¹

Experience the full interactive Multichannel News Release here: https://www.multivu.com/johnson-johnson/9331651-en-johnson-johnson-receives-fda-approval-imaavy-nipocalimab-aahu

"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," said Samantha Masterson, President and CEO, Myasthenia Gravis Foundation of America.^a "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."

gMG is a chronic, debilitating autoantibody disease for which significant unmet patient need exists for additional efficacious therapies with demonstrated safety profiles that offer sustained disease control.^2,3 Anti-AChR and anti-MuSK antibody positive individuals comprise ≥90% of the total antibody-positive gMG population.⁴ IMAAVY is an immunoselective therapy designed to substantially reduce immunoglobulin G (IgG), including harmful IgG autoantibodies, without additional detectable effects on other adaptive and innate immune functions.⁵

The approval is supported by data from the pivotal, ongoing Vivacity-MG3 study – the longest primary endpoint of a registrational trial of any FcRn blocker in adults with living with gMG. Highlights of the study include⁴:

• IMAAVY plus standard of care (SOC) provided superior disease control throughout 24 weeks when compared to placebo plus SOC, as measured by improvement in the MG-ADL^b score.⁴ This translates into patients regaining essential daily functions, such as chewing, swallowing, speaking and breathing.⁴ 
• Participants on IMAAVY plus SOC maintained improvements out to 20 months of follow-up in the ongoing open-label extension (OLE) study in gMG.⁶
• IMAAVY demonstrated a rapid and sustained reduction in autoantibody levels by up to 75% from the first dose and throughout a 24-week period of monitoring.⁴

"The clinical results we've seen with IMAAVY represent a significant milestone in the treatment of gMG," said Dr. Nicholas J. Silvestri, M.D., Professor of Neurology at University of Buffalo^d "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."

Results from the ongoing Vibrance Phase 2/3 pediatric study in anti-AChR and anti-MuSK antibody positive adolescents aged 12-17 years showed that IMAAVY plus SOC met its primary endpoint with a 69% reduction in total serum IgG over 24 weeks, and secondary endpoints of improvements in MG-ADL and QMG^c scales.⁷

IMAAVY has demonstrated a consistent safety profile across both Vivacity-MG3 and the ongoing Vibrance-MG studies, with comparable tolerability in adult and pediatric populations.^3,4 

"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," said David Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson Innovative Medicine. "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."

Johnson & Johnson is committed to supporting affordable access to all its treatments, including offering a patient support program called IMAAVY withMe in the United States. With this program, commercially insured patients who are prescribed IMAAVY may be eligible to receive their first treatment in as quickly as one week and may pay as little as $0 per infusion.

Health authority submissions seeking approval for nipocalimab in the treatment of gMG are currently under review with numerous regulatory authorities worldwide.

Editor's notes:

a. Ms. Masterson has not been paid for any media work.

b. MG-ADL (Myasthenia Gravis-Activities of Daily Living) provides a rapid clinical assessment of the patient's recall of symptoms impacting activities of daily living, with a total score range of 0 to 24; a higher score indicates greater symptom severity.⁸ 

c. QMG (Quantitative Myasthenia Gravis) is a 13-item assessment by a clinician that quantifies MG disease severity. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity.⁸ 

d. Dr. Nicholas J. Silvestri, M.D. has provided consulting, advisory, and speaking services to Johnson & Johnson. He has not been paid for any media work.

ABOUT GENERALIZED MYASTHENIA GRAVIS (gMG)

Myasthenia gravis (MG) is an autoantibody disease in which the immune system mistakenly makes antibodies (e.g., anti-acetylcholine receptor [AChR], anti-muscle-specific tyrosine kinase [MuSK] ), which target proteins at the neuromuscular junction and can block or disrupt normal signaling from nerves to muscles, thus impairing or preventing muscle contraction.^2,9,10 The disease impacts an estimated 700,000 people worldwide.² The disease affects both men and women and occurs across all ages, racial and ethnic groups, but most frequently starts in young women and older men.¹¹ Roughly 50 percent of individuals diagnosed with MG are women, and about one in five of those women are of child-bearing potential.^12,13,14 Approximately 10 to 15% of new cases of MG are diagnosed in pediatric patients 12-17 years of age.^15,16,17 Among juvenile MG patients, girls are affected more often than boys with over 65% of pediatric MG cases in the U.S. diagnosed in girls.^18,19,20

Initial disease manifestations are usually eye-related but approximately 85 percent of MG patients experience additional advancements to the disease manifestations—referred to as generalized myasthenia gravis (gMG). This is characterized by severe muscle weakness and difficulties in speech and swallowing.^{21,22,23,24,25} Approximately 100,000 individuals in the U.S. are living with gMG.²⁶ Vulnerable gMG populations, such as pediatric patients, have more limited therapeutic options.²⁷

ABOUT THE PHASE 3 VIVACITY-MG3 STUDY

The Phase 3 Vivacity-MG3 study (NCT04951622) was specifically designed to measure sustained efficacy and safety with consistent dosing in this unpredictable chronic condition where unmet need remains high. Antibody positive or negative adult gMG patients with insufficient response (MG-ADL ≥6) to ongoing SOC therapy were identified and 199 patients, 153 of whom were antibody positive, enrolled in the 24-week double-blind placebo-controlled trial.^4,28 Randomization was 1:1, nipocalimab plus current SOC (30 mg/kg IV loading dose followed by 15 mg/kg every two weeks) or placebo plus current SOC.⁴ Baseline demographics were balanced across arms (77 nipocalimab, 76 placebo).⁴ The primary efficacy endpoint was the comparison of the mean change from baseline to Weeks 22, 23, and 24 between treatment groups in the MG-ADL total score.⁴ A key secondary endpoint included change in QMG score. Long-term safety and efficacy were further assessed in an ongoing open-label extension (OLE) phase.²⁸ 

ABOUT THE PHASE 2/3 VIBRANCE-MG STUDY 

The Phase 2/3 Vibrance-MG study (NCT05265273) is an on-going open-label study to determine the effect of nipocalimab in pediatric participants with gMG.²⁹ Seven participants aged 12-17 years with a diagnosis of gMG as reflected by a Myasthenia Gravis Foundation of America (MGFA) Class of II through IV at screening, and an insufficient clinical response to ongoing, stable SOC therapy, have been enrolled in the trial.³⁰ Participants must have a positive blood test for either anti-AChR or anti-MUSK autoantibodies. The study consists of a screening period of up to four weeks, a 24-week open-label Active Treatment Phase during which participants receive nipocalimab intravenously every two weeks, and a Long-term Extension Phase; a safety follow-up assessment will be conducted at eight weeks after last dose.²⁹ The primary outcome of the study is the effect of nipocalimab on total serum IgG, safety and tolerability, and pharmacokinetics in pediatric participants with gMG at 24 weeks. Secondary endpoints include change in MG-ADL and QMG scores at 24 weeks.^29,30

ABOUT IMAAVY^TM (nipocalimab-aahu)

IMAAVY is a monoclonal antibody, designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) antibodies that underlie generalized myasthenia gravis (gMG) without additional detectable effects on other adaptive and innate immune functions. IMAAVY is currently approved for the treatment of gMG in adults and pediatric patients 12 years of age and older who are AChR or MuSK antibody positive.¹ 

Nipocalimab is continuing to be investigated across three key segments in the autoantibody space including Rare Autoantibody diseases, Maternal Fetal diseases mediated by maternal alloantibodies and Rheumatic diseases.^{28,31,32,33,34,35,36,37,38,39} The investigational monoclonal antibody is designed to bind with high affinity to block FcRn and reduce levels of circulating immunoglobulin G (IgG) auto and alloantibodies potentially without additional detectable effects on other adaptive and innate immune functions. 

The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have granted several key designations to nipocalimab including:  

• U.S. FDA Fast Track designation in hemolytic disease of the fetus and newborn (HDFN) and warm autoimmune hemolytic anemia (wAIHA) in July 2019, gMG in December 2021, fetal and neonatal alloimmune thrombocytopenia) FNAIT in March 2024 and Sjögren's disease (SjD) in March 2025
• U.S. FDA Orphan drug status for wAIHA in December 2019, HDFN in June 2020, gMG in February 2021, chronic inflammatory demyelinating polyneuropathy (CIDP) in October 2021 and FNAIT in December 2023
• U.S. FDA Breakthrough Therapy designation for HDFN in February 2024 and for Sjögren's disease in November 2024  
• U.S. FDA granted Priority Review in gMG in Q4 2024
• EU EMA Orphan medicinal product designation for HDFN in October 2019

WHAT IS IMAAVY™ (nipocalimab-aahu)?

IMAAVY™ is a prescription medicine used to treat adults and children 12 years of age and older with a disease called generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

It is not known if IMAAVY™ is safe and effective in children under 12 years of age. 

IMPORTANT SAFETY INFORMATION 

What is the most important information I should know about IMAAVY™?

IMAAVY™ is a prescription medicine that may cause serious side effects, including:

• Infections are a common side effect of IMAAVY™ that can be serious. Receiving IMAAVY™ may increase your risk of infection. Tell your healthcare provider right away if you have any of the following infection symptoms:
  • fever
  • chills
  • shivering
  • cough    
  • sore throat
  • fever blisters
  • burning when you urinate
• Allergic (hypersensitivity) reactions may happen during or up to a few weeks after your IMAAVY™ infusion. Get emergency medical help right away if you get any of these symptoms during or after your IMAAVY™ infusion:
  • a swollen face, lips, mouth, tongue, or throat
  • difficulty swallowing or breathing    
  • itchy rash (hives)
  • chest pain or tightness
• Infusion-related reactions are possible. Tell your healthcare provider right away if you get any of these symptoms during or a few days after your IMAAVY™ infusion:
  • headache
  • rash
  • nausea
  • fatigue    
  • dizziness
  • chills
  • flu-like symptoms
  • redness of skin

Do not receive IMAAVY™ if you have a severe allergic reaction to nipocalimab-aahu or any of the ingredients in IMAAVY™. Reactions have included angioedema and anaphylaxis.

Before using IMAAVY™, tell your healthcare provider about all of your medical conditions, including if you:

• ever had an allergic reaction to IMAAVY™.
• have or had any recent infections or symptoms of infection.
• have recently received or are scheduled to receive an immunization (vaccine). People who take IMAAVY™ should not receive live vaccines.
• are pregnant, plan to become pregnant, or are breastfeeding. It is not known whether IMAAVY™ will harm your baby.

Pregnancy Safety Study. There is a pregnancy safety study for IMAAVY™ if IMAAVY™ is given during pregnancy or you become pregnant while receiving IMAAVY™. Your healthcare provider should report IMAAVY™ exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com. 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. 

What are the possible side effects of IMAAVY™?
IMAAVY™ may cause serious side effects. See "What is the most important information I should know about IMAAVY™?"

The most common side effects of IMAAVY™ include: respiratory tract infection, peripheral edema (swelling in your hands, ankles, or feet), and muscle spasms.

These are not all the possible side effects of IMAAVY™. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information and Medication Guide for IMAAVY™ and discuss any questions you have with your doctor.

Dosage Form and Strengths: IMAAVY™ is supplied as a 300 mg/1.62 mL and a 1,200 mg/6.5 mL (185 mg/mL) single-dose vial per carton for intravenous injection.

ABOUT JOHNSON & JOHNSON 

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity.  

Learn more at https://www.jnj.com/ or at https://innovativemedicine.jnj.com/ 

Follow us at @JNJInnovMed.

Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. 

CAUTIONS CONCERNING FORWARD-LOOKING STATEMENTS 

This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of IMAAVY™. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

REFERENCES

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³⁰ Strober J et al. Safety and effectiveness of nipocalimab in adolescent participants in the open label Phase 2/3 Vibrance-MG clinical study. Presentation at American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting. October 2024.
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Media contact: Bridget Kimmel bkimmel@its.jnj.com

Investor contact: Lauren Johnson investor-relations@its.jnj.com

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SOURCE Johnson & Johnson

FAQ

What is IMAAVY, JNJ's new FDA-approved drug for myasthenia gravis?

IMAAVY (nipocalimab-aahu) is a human FcRn-blocking monoclonal antibody approved by the FDA for treating generalized myasthenia gravis (gMG). It's the first and only FcRn blocker approved for both anti-AChR and anti-MuSK antibody positive adults and children aged 12 and older.

How effective is Johnson & Johnson's IMAAVY in treating gMG symptoms?

IMAAVY demonstrated rapid symptom relief and disease control lasting up to 20 months in clinical trials. It reduced harmful antibody levels by up to 75% from the first dose and maintained improvements throughout 24 weeks of monitoring.

What patient population can use JNJ's IMAAVY treatment?

IMAAVY is approved for the broadest gMG patient population, including both adults and pediatric patients 12 years and older who are anti-AChR or anti-MuSK antibody positive, which represents over 90% of antibody-positive gMG patients.

How much does JNJ's IMAAVY cost for patients with commercial insurance?

Through the IMAAVY withMe support program, commercially insured patients may pay as little as $0 per infusion and can receive their first treatment in as quickly as one week.

What were the clinical trial results for JNJ's IMAAVY in pediatric patients?

In the Vibrance Phase 2/3 study, IMAAVY showed a 69% reduction in total serum IgG over 24 weeks in adolescents aged 12-17 years, with improvements in both MG-ADL and QMG scales, demonstrating consistent safety across adult and pediatric populations.