Significant improvement in daily function
and muscle weakness†
*As measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale.
†As measured by the Quantitative Myasthenia Gravis (QMG) scale.
Significant improvement in daily function
Why IMAAVY™?
A 24-week clinical study explored the effectiveness and safety of IMAAVY in adult patients living with antibody-positive gMG (including those with anti-AChR or anti-MuSK gMG).
Significant improvement in daily function
4+
point reduction in
MG-ADL on average
Patients taking IMAAVY + current gMG treatment experienced a 4.7-point improvement in MG-ADL on average. Patients taking placebo + current gMG treatment experienced a 3.3-point improvement on average. This was measured using results averaged from Weeks 22, 23, and 24 of the study compared to baseline.
What could an improvement in MG-ADL total score mean?
The MG-ADL scale assesses the impact of gMG on 8 daily-function items (talking, chewing, swallowing, breathing, brushing teeth or hair, rising from a chair, double vision, and eyelid droop) that are typically affected in gMG. A lower MG-ADL score can indicate improvement in the ability to perform these 8 activities of daily living.
See the full MG-ADL scale to learn more
Individual results may vary.
Talk to your healthcare provider to see if IMAAVY is right for you.
Reduction in MG-ADL Total Score
in a 24-Week Study
Reduction in MG-ADL Total Score in a 24-Week Study
IMAAVY doses were given once every 2 weeks after a starter dose.
Patients received either IMAAVY + current gMG treatment or placebo + current gMG treatment.
‡This was measured using results averaged from Weeks 22, 23, and 24 of the study compared to baseline.
Improved muscle weakness
4+
point reduction in
QMG on average
Patients taking IMAAVY + current gMG treatment experienced a 4.9-point improvement in QMG on average. Patients taking placebo + current gMG treatment experienced a 2.1-point improvement on average. This was measured using results averaged from Weeks 22 and 24 of the study compared to baseline.
What could an improvement in QMG total score mean?
The QMG scale assesses muscle weakness based on 13 items. A lower QMG score can indicate improvement in muscle weakness or less muscle weakness.
See the full QMG scale
to learn more
Individual results may vary. Talk to your healthcare provider to see if IMAAVY is right for you.
Reduction in QMG Total Score
in a 24-Week Study
IMAAVY doses were given once every 2 weeks after a starter dose.
Patients received either IMAAVY + current gMG treatment or placebo + current gMG treatment.
§This was measured using results averaged from Weeks 22 and 24 of the study compared to baseline.
Reduction in QMG Total Score in a 24-Week Study
IMAAVY doses were given once every 2 weeks after a starter dose.
Patients received either IMAAVY + current gMG treatment or placebo + current gMG treatment.
§This was measured using results averaged from Weeks 22 and 24 of the study compared to baseline.
IMAAVY plus current gMG treatment compared to placebo plus current gMG treatment was studied in 153 adults, which included anti-AChR or anti-MuSK antibody-positive gMG patients.
The safety was evaluated across the full population.
The effectiveness of IMAAVY was measured using the average change in daily function (MG-ADL)‖ and muscle weakness (QMG)¶ scores. Patients received either IMAAVY + their current gMG treatment or placebo + their current gMG treatment once every 2 weeks.
This study required patients to meet the following criteria:
- Adult (aged 18 or older)
- Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IV. This is a system that characterizes how severe someone’s MG symptoms are
- MG-ADL score greater than or equal to 6
- On a stable dose of other gMG treatments, including acetylcholinesterase (AChE) inhibitors, steroids, or non-steroidal immunosuppressive therapies, taken together or separately
The MG-ADL is a scale that measures your ability to perform 8 daily tasks typically affected by your gMG. Some items in the scale include talking, brushing your teeth, and chewing.
The QMG is a 13-item scale that measures muscle weakness. Some items in the scale include arm strength, leg strength, and grip strength.
||This was measured using results averaged from Weeks 22, 23, and 24 of the study compared to baseline.
¶This was measured using results averaged from Weeks 22 and 24 of the study compared to baseline.
Measuring the impact of your gMG symptoms
MG-ADL scale
The MG-ADL scale assesses the impact of gMG on 8 daily-function items that are typically affected in gMG, based on information that you provide to your healthcare provider.
Talking
Swallowing
Brushing teeth or hair
Double vision
Chewing
Breathing
Rising from chair
Eyelid droop
The MG-ADL is scored on a scale of 0–3 in each symptom category.
- A “2” or “3” can mean the activity is difficult or even impossible for you
- A “1” or a “0” can mean the activity is either less difficult or not difficult at all
- The total score ranges from 0 to 24, with higher scores indicating more severe gMG symptoms
You might think of your MG-ADL score like a golf score or other game in which the lowest number is preferred. A low MG-ADL score means your gMG symptoms are less severe.
QMG Scale
The QMG scale assesses muscle weakness based on 13 items. Your healthcare provider will take you through the QMG evaluation and record the results.
Double vision and upper eyelid droop
Ability to drink water
Counting out loud
Grip strength
Face and neck
muscle strength
Breathing capacity
Arm strength
Leg strength
Like the MG-ADL, the QMG is also scored on a scale of 0–3 in each symptom category.
- A "2" or "3" can mean the activity is difficult or even impossible for you
- A "1" or a "0" can mean the activity is either less difficult or not difficult at all
- The total score ranges from 0 to 39, with higher scores indicating more muscle weakness
Like the MG-ADL scale, lower numbers on the QMG mean a better score. However, your healthcare provider records those scores differently. You might think of it like a fitness exam in which your healthcare provider is testing to see how well you can perform each task.
Side effects & safety
What are the possible side effects of IMAAVY?
The most common side effects in people with gMG treated with IMAAVY include:
- infection in parts of your body that you use for breathing (respiratory tract infection)
- swelling in your hands, ankles, or feet (peripheral edema)
- muscle spasms
IMAAVY is a prescription medicine that may cause serious side effects, including:
- Infections. 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 symptoms of infection:
- fever
- chills
- shivering
- cough
- sore throat
- fever blisters
- burning when you urinate
- Allergic (hypersensitivity) reactions. Allergic 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, which may be part of a serious allergic reaction:
- swelling of your 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 the following symptoms during or a few days after your infusion of IMAAVY:
- headache
- rash
- nausea
- fatigue
- dizziness
- chills
- flu-like symptoms
- redness of skin
These are not all of the possible side effects of IMAAVY.
If you have a reaction during your IMAAVY infusion, your healthcare provider may decide to give IMAAVY more slowly or to stop your infusion.
Please read the Important Safety Information and the Medication Guide for IMAAVY to learn more about these and other risks for IMAAVY. Discuss any questions you have with your healthcare provider.
View full list of side effects as a table
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The safety of IMAAVY was evaluated in a broad
gMG population
Pediatric patients ages 12 to 16
years who were anti-AChR+
Adults who were anti-AChR+ or
anti-MuSK+ including women of
childbearing age
*Included women of childbearing age.
How IMAAVY works
IMAAVY is designed to reduce harmful IgG antibodies, including
anti-AChR and anti-MuSK, by binding and blocking FcRn receptors.
These antibodies can cause gMG symptoms.
In gMG, sometimes there are harmful immunoglobulin G (IgG) antibodies such as harmful anti-AChR and anti-MuSK antibodies that can target receptors in your muscles, preventing those muscles from working properly. This is what could cause gMG symptoms, as your nerves and muscles are communicating less effectively.
Neonatal fragment crystallizable receptor (FcRn) is a protein in your body that can help keep harmful IgG antibodies circulating in your body longer, where they can continue to attach to muscle receptors and interfere with signals sent from nerves.
Because IMAAVY binds and blocks FcRn receptors, harmful IgG antibodies, including anti-AChR and anti-MuSK, are reduced.
Learn more about harmful antibodies
IMAAVY binds and blocks FcRn.
This can help prevent IgG, including harmful IgG antibodies, from binding to FcRn, which leads to the breakdown of IgG antibodies.
IgG antibody levels are reduced, including the harmful anti-AChR and anti-MuSK antibodies. These harmful antibodies can cause gMG symptoms.
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