We are pleased to share an important update from argenx regarding the treatment landscape for generalized myasthenia gravis (gMG).
The U.S. Food and Drug Administration (FDA) has approved a label expansion for VYVGART (efgartigimod alfa-fcab) and VYVGART Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) to include all adult patients living with gMG, regardless of antibody status. This means the therapies are now approved for patients who are anti-AChR antibody positive, anti-MuSK antibody positive, anti-LRP4 antibody positive, as well as those who are triple seronegative.
This approval is based on results from the Phase 3 ADAPT SERON study, which demonstrated rapid, statistically significant, and clinically meaningful improvements in daily functioning compared to placebo. Improvements were observed across symptoms impacting daily life, including speech, vision, swallowing, and physical function.
This milestone is particularly meaningful for individuals who do not have detectable AChR antibodies—a community that has historically faced limited inclusion in clinical research and fewer targeted treatment options.
We recognize the important role you play in supporting individuals living with MG and are committed to keeping you informed as new developments emerge.
Monica Seles Speaks Out About Living with Myasthenia Gravis and partners with argenx in the Go for Greater initiative
Posted by Giselle Murillo
Nine-time Grand Slam champion Monica Seles has revealed her diagnosis with myasthenia gravis (MG), which she has been living with since 2022.
She first noticed symptoms such as double vision and weakness in her arms and legs, which made everyday tasks difficult, and is now using her platform to educate and support others.
Partnering with argenx’s Go for Greater initiative, Seles hopes to raise awareness, connect patients with support resources, and inspire advocacy in the MG community. “I can raise awareness of this disease, empower patients to advocate for themselves, and help them connect with the MG community,” she says.
Argenx announces innovative pre-filled syringe self-injection option for adults with gMG
Posted by myasthenia
VYVGART Hytrulo prefilled syringe for self-injection (single-dose subcutaneous injection: 200 mg/mL of efgartigimod alfa and 2,000 U/mL of hyaluronidase) has been approved by the U.S. FDA for the treatment of adults with anti-AChR antibody-positive generalized myasthenia gravis (gMG). The VYVGART Hytrulo prefilled syringe is a self-injection that takes about 20-30 seconds.* It is injected under the skin (subcutaneously). Patients and/or their caregivers will receive in-person training at home or in their doctor’s office until they’re ready to inject on their own. They’ll also get a demonstration kit to help them practice.
argenx will provide support and educational resources to patients who are prescribed VYVGART Hytrulo through our My VYVGART Path Patient Support Program. Resources are available throughout the entire treatment journey and include: disease and product education, access to support and benefits verification, and financial assistance programs for eligible patients. If patients are self-injecting with the VYVGART Hytrulo prefilled syringe, a Nurse Case Manager can also provide additional educationalresources on self-injection.
On behalf of all of us at argenx, I personally want to thank you for your support. Your organization’s continued partnership has helped us bring this milestone to fruition for the gMG community. We are so honored to have you as an argenx advocacy partner.
Do not take VYVGART HYTRULO if you are allergic to efgartigimod alfa, hyaluronidase, or any of the ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting.
Before taking VYVGART HYTRULO, tell your healthcare provider about all of your medical conditions, including if you:
have an infection or fever.
have recently received or are scheduled to receive any vaccinations.
have any history of allergic reactions.
have kidney (renal) problems.
are pregnant or plan to become pregnant. It is not known whether VYVGART HYTRULO will harm your unborn baby.
o Pregnancy Exposure Registry. There is a pregnancy exposure registry for women who use VYVGART HYTRULO during pregnancy. The purpose of this registry is to collect information about your health and your baby. Your healthcare provider can enroll you in this registry. You may also enroll yourself or get more information about the registry by calling 1-855-272-6524 or going to VYVGARTPregnancy.com
are breastfeeding or plan to breastfeed. It is not known if VYVGART HYTRULO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
VYVGART HYTRULO can cause side effects which can be serious, including:
Infection. VYVGART HYTRULO may increase the risk of infection. If you have an active infection, your healthcare provider should delay your treatment with VYVGART HYTRULO until your infection is gone. Tell your healthcare provider right away if you get any of the following signs and symptoms of an infection:
o fever
o chills
o frequent and painful urination
o cough
o pain and blockage of nasal passages
o wheezing
o shortness of breath
o sore throat
o excess phlegm
o nasal discharge
Allergic reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions that can be severe. These reactions can happen during, shortly after, or weeks after your VYVGART HYTRULO injection. Tell your healthcare provider or get emergency help right away if you have any of the following symptoms of an allergic reaction:
o rash
o swelling of the face, lips, throat, or tongue
o shortness of breath
o hives
o trouble breathing
o low blood pressure
o fainting
Infusion or injection-related reactions. VYVGART HYTRULO can cause infusion or injection-related reactions. These reactions can happen during or shortly after your VYVGART HYTRULO injection. Tell your healthcare provider if you have any of the following symptoms of an infusion or injection-related reaction:
o high blood pressure
o chills
o shivering
o chest, stomach, or back pain
The most common side effects of VYVGART HYTRULO include respiratory tract infection, headache, urinary tract infection, and injection site reactions.
These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is VYVGART HYTRULO® (efgartigimod alfa and hyaluronidase-qvfc)?
VYVGART HYTRULO is a prescription medicine used to treat adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
It is not known if VYVGART HYTRULO is safe and effective in children.
