Vyvgart (efgartigimod alfa-fcab)
Vyvgart (efgartigimod alfa-fcab) is a medication used to treat adults with generalized Myasthenia Gravis (gMG).
- Disease Indications : Myasthenia Gravis
- Usage : Intravenous
Medicine approved by
- European Medical Agency (EMA)
- Food and Drug Administration (FDA)
- Pharmaceuticals and Medical Devices Agency (PMDA)
Details
What is Vyvgart (efgartigimod alfa-fcab) for?
Vyvgart (efgartigimod alfa-fcab) is a neonatal Fc receptor blocker used to treat generalized Myasthenia Gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
It is available in vial form for intravenous infusion, each containing 20 mg/mL efgartigimod alfa-fcab.
How does Vyvgart (efgartigimod alfa-fcab) work?
Myasthenia gravis (MG) is a rare, chronic, neuromuscular disorder. It causes weakness in skeletal muscles (voluntary muscles) of the whole body. With normal muscle function, nerve impulses originating in the brain travel through nerves towards the muscle fibers. At the junction between the nerve and the muscle, a chemical called acetylcholine is released, which is used to communicate.
In MG, the body’s immune system makes antibodies against acetylcholine receptors (AChR) present at this junction, which results in muscle weakness.
Vyvgart is designed to lower levels of these antibodies. It does so by blocking the activity of the protein neonatal Fc receptor (FcRn), which normally helps protect certain antibodies from being broken down.
Where has Vyvgart (efgartigimod alfa-fcab) been approved?
Vyvgart (efgartigimod alfa-fcab) was approved for the treatment of people with gMG by:
- The Food and Drug Administration (FDA), USA on December 17, 2021.
- The Pharmaceuticals and Medical Devices Agency (PMDA), Japan on January 20, 2022.
Vyvgart (efgartigimod alfa-fcab) was granted Fast Track and Orphan Drug designations by the FDA.
A decision on Vyvgart’s approval in Europe is expected by mid-2022.
Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.
How is Vyvgart (efgartigimod alfa-fcab) taken?
The standard dosage is:
- 10 mg/kg given as an intravenous infusion (drip) over one hour once weekly for 4 weeks
- In patients weighing 120 kg or more: 1200 mg (3 vials) per infusion
Subsequent treatment cycles should be given based on clinical evaluation. The safety of starting a new treatment cycle sooner than 50 days from the start of the previous cycle has not been established.
If you miss a scheduled infusion, you may be given Vyvgart up to 3 days after the scheduled time point. Thereafter, resume the original dosing schedule until the treatment cycle is completed.
Complete information about Vyvgart (efgartigimod alfa-fcab) dosage (preparation) and administration can be found in the official prescribing information listed in our references section.
Note: Please consult with your treating doctor for personalised dosing.
Are there any known adverse reactions or side effects of Vyvgart (efgartigimod alfa-fcab)?
Common adverse reactions
The most common adverse reactions (≥10% of patients) listed in the prescribing information include:
- Respiratory tract infections
- Headache
- Urinary tract infection
Serious adverse reactions
The serious adverse reactions listed in the prescribing information include:
- Infection
- Undesirable immune reactions (hypersensitivity reactions)
Use in a specific population
Before starting with treatment, tell your doctor about all of your medical conditions, including if you:
- Have a history of infection or you think you have an infection
- Plan to receive any vaccines. Immunization with live-attenuated or live vaccines is not recommended during treatment with Vyvgart
- Are pregnant or planning to be pregnant and are breastfeeding or plan to breastfeed
For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.
References
- Full prescribing information [FDA]: Vyvgart (efgartigimod alfa-fcab) [PDF] Argenx, Dec 2021
- What is Myasthenia Gravis? Myasthenia.org, cited Dec 2021
- FDA Approves Vyvgart for Adults With Most Common Form of gMG Myastheniagravisnews.com, Dec 2021
- FDA Approves New Treatment for Myasthenia Gravis FDA press release, Dec 2021
- Argenx announces VYVGART™ approval in Japan for the treatment of generalized myasthenia gravis Argenx press release, Jan 2022
Clinical trials
The Food and Drug Administration (FDA) approval of Vyvgart (efgartigimod alfa-fcab) for treatment of adults with generalized Myasthenia Gravis (gMG) was based on data of the study ADAPT (NCT03669588).
ADAPT was a randomised, double-blind, placebo-controlled, phase 3 trial that involved 167 patients with gMG. Patients were randomized to receive either Vyvgart (10 mg/kg) or placebo as four infusions per cycle (one infusion per week) for 26 weeks, with a maximum of three treatment cycles over the study’s course.
Results
The main efficacy outcome of ADAPT was Myasthenia Gravis Activities of Daily Living (MG-ADL) responders in the first treatment cycle, which is a measure of the impact of the disease on daily function.
Vyvgart was able to ease disease symptoms compared to placebo in myasthenia gravis patients: 68% of patients in the Vyvgart group were MG-ADL responders in cycle 1, versus 30% in the placebo group.
Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Vyvgart (efgartigimod alfa-fcab) for the approved indication.
References
- FDA Approves New Treatment for Myasthenia Gravis FDA press release, Dec 2021
- An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness ADAPT trial, cited Dec 2021
- Safety, efficacy, and tolerability of efgartigimod in patients with generalised myasthenia gravis (ADAPT): a multicentre, randomised, placebo-controlled, phase 3 trial Howard Jr, JF et al., The Lancet Neurology, Jul 2021
- Full prescribing information [FDA]: Vyvgart (efgartigimod alfa-fcab) [PDF] Argenx, Dec 2021
Price & Costs
Vyvgart (efgartigimod alfa-fcab) price in other currencies*
| Package | Euro | Australian dollars | Canadian dollar | New Zealand dollar | Nigerian naira | Singapore dollar | Pound sterling | United States dollar |
|---|---|---|---|---|---|---|---|---|
| One vial of 400 mg/20 mL (20 mg/mL) | 13184 EUR | 21766 AUD | 19672 CAD | 23946 NZD | 21902247 NGN | 18624 SGD | 10869 GBP | 13885 USD |
*The prices listed above are based on the cheapest package size and strength everyone.org has access to. Please make an enquiry for more specific pricing. The prices listed above are a guide only, we operate in Euros.
Vyvgart (efgartigimod alfa-fcab) treatment costs
The cost for a monthly or yearly treatment of Vyvgart (efgartigimod alfa-fcab) depends on your prescription requirements which includes the dosage in mg/ml and medicine type (Single-dose vial).
The price of the medicines you see on sale is the cost set by the manufacturer. In addition, shipping costs and a Named Patient support fee will apply.
Make an enquiry and we will help you calculate the total price to buy Vyvgart (efgartigimod alfa-fcab) online and have it delivered where you live. From your side, we’ll simply need a prescription from your treating doctor. In some countries we might also need an import license. Our Patient Support team will guide you throughout the process.
Vyvgart (efgartigimod alfa-fcab) price and additional costs
- The price of Vyvgart (efgartigimod alfa-fcab)
- Our Named Patient support fee
- Shipping costs
- Payment methods when you buy Vyvgart (efgartigimod alfa-fcab)
The base cost of each medicine is set by the manufacturer. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise.
everyone.org provides access to Vyvgart (efgartigimod alfa-fcab) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. The Named Patient support fee is tiered relative to the cost of the medicine.
The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order.
When you buy Vyvgart (efgartigimod alfa-fcab), you can make the payment by bank transfer or by credit card. Payments are fully encrypted and secure. When paying by credit card, you can pay online once you have received your order confirmation. Please be aware that a 2.8% fee applies when paying by credit card.
Vyvgart (efgartigimod alfa-fcab) reimbursement
It might be possible for you to claim the cost of Vyvgart (efgartigimod alfa-fcab) via your country's healthcare system. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. The best thing would be to check with your country's own health ministry. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options.
Medical insurance
Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. In some limited circumstances, we do accept insurance. Contact us for more details. You can pay by bank transfer or credit card.
Crowdfunding
Crowdfunding might also be an option for you. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Here are some crowdfunding platforms where you can seek support: GoFundMe, GiveForward, FundRazr and Watsi.
Shipping
Cold chain shipping
Some medicinal ingredients are susceptible to damage from heat, light and handling. Using "cold chain" delivery, specialised medical couriers have temperature regulated boxes and vehicles to ensure that the medicine is uncompromised. For that reason, cold chain shipping can be more expensive than regular shipping.
Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. If you would like your order to be shipped by a specific courier, please inform us when you place the order.
Our standard delivery time varies from 5 to 10 working days.
The shipping cost depends on the medicine and the destination country. After making an enquiry, you will receive a detailed quote that includes the shipping costs.
You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for.
Our Process
Four steps to access the medicines you need
How and where to access and buy Vyvgart: You can access Vyvgart from everyone.org if the drug has not been approved or is not available in your country.
- Step 1: You send a request for your medicine online
- Step 2: We verify your prescription and medical details
- Step 3: We source your medicine
- Step 4: We deliver your medicine
Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. They will be there to support and guide you in anyway possible to help you get the medicine you need.
Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need.
Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval.
After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. We will work hard to keep you informed at every step along the way and get your medicine to you quickly and safely. To date we have successfully delivered packages to over 75 countries around the world.
Contact Patient Support
If you have any questions or need any help, contact our Patient Support Team. We will get in touch with you within 24 hours from Monday to Friday between 9:00 and 10:00 CET.
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