A woman stands in the bleachers of a soccer field with her husband and daughter. She is cheering joyfully for her team.
A woman stands in the bleachers of a soccer field with her husband and daughter. She is cheering joyfully for her team.

VYVGART can help you do more with your days Proven to improve daily abilities and reduce muscle weakness.

GENERALIZED MYASTHENIA GRAVIS

doesn’t get to stop this cheering section

VYVGART for IV infusion improved daily abilities and reduced muscle weakness

The study explored the effectiveness and safety of VYVGART for IV infusion in adults with anti-AChR antibody positive gMG. The two main goals of the study were to see how VYVGART for IV infusion improved daily abilities and reduced muscle weakness in patients taking VYVGART for IV infusion plus their current treatment, compared to those taking placebo plus their current treatment.

gMG=generalized myasthenia gravis; IV=intravenous

More than 2x as many patients saw improved daily abilities in the first treatment cycle

such as talking, chewing, swallowing, breathing, brushing teeth, combing hair, getting up when seated, and not having double vision or eyelid droop as often

68% (44 of 65) of patients who added VYVGART for IV infusion to their current gMG treatment significantly improved their ability to perform daily activities, as measured by the MG-ADL scale.*

Compared to 30% (19 of 64) of patients on placebo plus their current gMG treatment.

Reduced gMG symptoms compared to placebo plus current gMG treatment

smile chart updated

Average reduction in MG-ADL score during treatment cycle 1

Swipe to see full graph

a Patients did not come in for an evaluation at week 9.
MG-ADL=Myasthenia Gravis Activities of Daily Living

 Average change in MG-ADL score
WeekVYVGART for IV infusion
+ current gMG treatment		Placebo + current gMG treatment
000
1-2.2-1.1
2-3.7-1.4
3-4.1-1.4
4-4.6-1.8
5-4.4-1.8
6-4.1-1.4
7-3.4-1.7
8-2.2-1.7
9a--
10-1.6-1.0

a Patients did not come in for an evaluation at week 9.

VYVGART for IV infusion was determined to be effective if a patient’s MG-ADL score decreased by 2 or more points and stayed at that level for 4 weeks or more in a row, with the first improvement occurring no later than 1 week after the last infusion of treatment cycle 1.

Learn more about MG-ADL and symptom tracking

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More than 4x as many patients saw reduced muscle weakness in the first treatment cycle

during movements like making facial expressions, gripping and holding things, holding up their limbs, and using their eyes

63% (41 of 65) of patients who added VYVGART for IV infusion to their current gMG treatment saw a significant reduction in muscle weakness, as measured by the QMG scale.†

Compared to 14% (9 of 64) of patients on placebo plus their current gMG treatment.

The ADAPT study:
VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG. The primary goals of the study were to examine effectiveness (improved daily abilities and reduced muscle weakness) and safety for FDA approval of VYVGART for IV infusion. The study examined the effectiveness and safety of VYVGART for IV infusion in 167 adults (18 years or older) with gMG. In addition to their current treatment, patients received either VYVGART for IV infusion or placebo.

*Improvement maintained for 4 or more weeks was measured by a decrease of 2 or more points on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale, with the first reduction occurring no later than 1 week after the last infusion of treatment cycle 1. The MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG.

†Improvement maintained for 4 or more weeks was measured by a decrease of 3 or more points on the Quantitative Myasthenia Gravis (QMG) scale, with the first reduction occurring no later than 1 week after the last infusion of treatment cycle 1. The QMG scale assesses muscle weakness in gMG based on 13 items. Each item is assessed on a 4-point scale, where a score of 0 represents no muscle weakness and a score of 3 represents severe muscle weakness. Total scores range from 0 to 39, with a higher score meaning muscle weakness is more severe.

MG-ADL=Myasthenia Gravis Activities of Daily Living; QMG=Quantitative Myasthenia Gravis

VYVGART for IV infusion was evaluated in a global study of adults with anti-AChR antibody positive gMG.

The study examined the effectiveness and safety of VYVGART for IV infusion in 167 adults (18 years or older) with gMG. In addition to their current gMG treatment, patients received either VYVGART for IV infusion or placebo.

Patients in this study needed to meet the following criteria:

  • Adult (18 or older)
  • Myasthenia Gravis Foundation of America (MGFA) clinical classification class II to IV
  • MG-ADL score of 5 or more
  • On a stable dose of their current gMG treatment throughout the study

Patients represented a range of adults with gMG:​

  • Median time since gMG diagnosis was 9 years
  • MGFA class ranged from II to IV at the start of the study

The MG-ADL scale was used to measure gMG symptoms:

  • The MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG: the ability to speak, chew, swallow, breathe, brush teeth or comb hair, and get out of a chair, as well as the frequency of double vision and eyelid droop
  • Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG
  • VYVGART for IV infusion was determined to be effective if an anti-AChR antibody positive patient’s MG-ADL score decreased by 2 or more points and stayed at that level for 4 weeks or more in a row, with the first improvement occurring no later than 1 week after the last infusion of treatment cycle 1

MGFA=Myasthenia Gravis Foundation of America

Additional data

The following data points were not the main goals of the study and do not carry the same weight as the main goals of the study. No reliable conclusions can be drawn about the effectiveness or safety of VYVGART for IV infusion based on these data points. Talk to your neurologist if you have any questions.

MG-ADL data during treatment cycle 1

of patients who added VYVGART for IV infusion to their current gMG treatment were observed to have an MG-ADL score of 0 or 1, which means minimal or no symptoms, at at least one visit during their first treatment cycle

of patients on placebo plus their current gMG treatment were observed to have an MG-ADL score of 0 or 1, which means minimal or no symptoms, at at least one visit during their first treatment cycle

The MG-ADL scale is an assessment tool that measures the severity of 8 common symptoms of gMG. Each item is scored on a 4-point scale—a score of 0 means “normal,” and a score of 3 means “loss of ability.” The total score can range from 0 to 24 points, with a higher score showing more severe gMG.

MG-ADL data after 2 treatment cycles

78% (51 of 65)

of patients who added VYVGART for IV infusion to their current gMG treatment were observed to have an MG-ADL response by the time they completed a second treatment cycle‡

44% (28 of 64)

of patients on placebo plus their current gMG treatment were observed to have an MG-ADL response by the time they completed a second treatment cycle‡

MG-ADL response was defined by a decrease of 2 or more points on the MG-ADL scale, maintained for 4 or more weeks.

‡44 of 65 patients on VYVGART for IV infusion had an MG-ADL response during treatment cycle 1. Of the 21 patients who didn’t have a response, 7 responded during the second treatment cycle. 19 of 64 patients on placebo plus their current gMG treatment had an MG-ADL response during treatment cycle 1. Of the 45 patients who didn't have a response, 9 responded during the second treatment cycle.

Demonstrated safety profile

In the study, the following side effects were reported in at least 5% of patients on VYVGART for IV infusion plus their current gMG treatment and more frequently than in patients on placebo plus their current gMG treatment.

Side effectVYVGART for IV infusion + current gMG treatment
84 patients		Placebo + current gMG treatment
83 patients
Respiratory tract infection33%29%
Headache32%29%
Urinary tract infection10%5%
Tingling sensation7%5%
Muscle pain6%1%

Most infections in patients on VYVGART for IV infusion were mild to moderate. Additionally, more patients on VYVGART for IV infusion compared to placebo plus current gMG treatment had lower white blood cell counts that were mild to moderate in severity.

VYVGART for IV infusion may increase the risk of allergic reactions including rash, swelling under the skin, and shortness of breath. It may also increase the risk of serious allergic reactions such as trouble breathing and decrease in blood pressure leading to fainting, as well as infusion-related reactions including increase in blood pressure, chills, shivering, and chest, abdominal, and back pain. These reactions can occur during or after treatment and can cause doctors to pause or, in some cases, stop treatment.

Taking VYVGART during pregnancy?

Consider sharing your experience with argenx by participating in the Pregnancy Registry. It’s a way to provide information about your health and your baby’s health during your pregnancy. Learn more by calling 1-855-272-6524, visiting VYVGARTpregnancy.com, or talking to your healthcare provider.

Talk to your neurologist to see if VYVGART is right for you

The VYVGART Doctor Discussion Guide can be used to help you discuss with your neurologist your current gMG symptoms and how they impact your daily abilities.

GET THE DISCUSSION GUIDE

Things to discuss with your doctor before starting VYVGART

vaccine

No specific vaccines required to start treatment

Talk to your doctor about age-appropriate vaccines before you start treatment.

drop

No routine lab monitoring required

Routine lab monitoring isn’t required, but your doctor will still monitor your response to treatment and look out for possible side effects.

mg-adl

Your MG-ADL score

Find out what your current score is and how VYVGART may improve it.

safety

Safety

Ask about the common side effects you may experience on VYVGART.

location

Location

Find out where you may get treatment based on your needs and preferences.

VYVGART for IV infusion is the #1 most prescribed FDA-approved biologic treatment for adults with anti-AChR antibody positive gMG§

VYVGART for IV infusion has been used for more than 2 years.

As of September 2023, ~4000 patients are enrolled in the My VYVGART Path patient program.||

VYVGART is widely available

>90%

VYVGART for IV infusion is covered for >90% of commercial and Medicare insured patients

Multiple treatment cycles are possible with the first prescription

>90%

of commercial and Medicare insured patients have coverage allowing for an initial authorization of VYVGART for IV infusion for at least 6 months. This can allow for multiple infusion cycles with the first prescription

§Based on IQVIA LAAD data from January 2023 to December 2023. Data is based on validated claims of VYVGART for IV infusion and other biologics that have been approved by FDA for the treatment of adults with anti-AChR antibody positive gMG. All claims are associated with patients who received two confirmed diagnoses of anti-AChR antibody positive gMG. Patients who were prescribed more than one of the biologics in this data set were counted for each biologic prescribed.
||Based on MY VYVGART PATH enrollment as of September 26, 2023.
¶Based on policy reporter data as of January 2024.
AChR=acetylcholine receptor; gMG=generalized myasthenia gravis; LAAD=Longitudinal Access and Adjudication Data

Getting started with VYVGART

How VYVGART works

See how VYVGART blocks harmful AChR antibodies, the main cause of gMG symptoms.

See the science

VYVGART dosing

Breaks between VYVGART treatment cycles are personalized to you. Find out how to work with your neurologist to make the most of your treatment plan.

Learn about personalized breaks

Real Stories on VYVGART for IV infusion

This video series features real people who speak about the impact of living with anti-AChR antibody positive gMG—and their experiences with VYVGART for IV infusion.

Explore the video series

Get the latest VYVGART updates

Sign up to get the latest information about VYVGART sent straight to your inbox. 

Sign Up Now
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Still have questions? Call 1-833-VYVGART (1-833-898-4278) to speak with an educator about gMG, how VYVGART works, study data, cost and coverage, and more.

Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

VYVGART and VYVGART HYTRULO may cause serious side effects, including:

  • Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
  • Allergic Reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
  • Infusion-Related Reactions. VYVGART and VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.

Before taking VYVGART or VYVGART HYTRULO, tell your doctor if you:

  • take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
  • have received or are scheduled to receive a vaccine (immunization), or
  • have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

What are the common side effects of VYVGART and VYVGART HYTRULO?

The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.

These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.

What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?

VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.

Do not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. Do not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART and VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.

VYVGART and VYVGART HYTRULO may cause serious side effects, including:

  • Infection. VYVGART and VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.
  • Allergic Reactions (hypersensitivity reactions). VYVGART and VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.
  • Infusion-Related Reactions. VYVGART and VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain.

Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART or VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction.

Before taking VYVGART or VYVGART HYTRULO, tell your doctor if you:

  • take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,
  • have received or are scheduled to receive a vaccine (immunization), or
  • have any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding.

What are the common side effects of VYVGART and VYVGART HYTRULO?

The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives.

These are not all the possible side effects of VYVGART and VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088.

What is VYVGART® (efgartigimod alfa-fcab) for intravenous (IV) infusion and what is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc) for subcutaneous injection?

VYVGART and VYVGART HYTRULO are both prescription medicines, each used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).

Please see the full Prescribing Information for VYVGART and the full Prescribing Information for VYVGART HYTRULO, and talk to your doctor.

Questions? Call 1-833-VYVGART
(1-833-898-4278)

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Prescribing Information
VYVGART for IV infusion Prescribing Information VYVGART Hytrulo for subcutaneous injection Prescribing Information

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