Vyvgart

Pharmaceutical company: Argenx

To move our bodies, signals must be sent from the brain, down specialised cells called nerves to the muscle. Acetylcholine receptors play a key role in passing the signal from nerve cells to the muscle. In myasthenia gravis, the immune system attacks the acetylcholine receptors. This means the nerve cells cannot send a strong signal to muscles, leading to muscle weakness.

Vyvgart works by reducing the effect of the immune system on the acetylcholine receptors. Specifically, Vyvgart reduces the levels of molecules called IgG antibodies. IgG antibodies are produced by the immune system to help protect the body from foreign substances, like bacteria. However, sometimes IgG antibodies can target our own cells. By reducing the levels of IgG antibodies, stronger signals should be able to be sent to the muscles.

Vyvgart come as a liquid and can either be administered through an injection under the skin (subcutaneous injection) or directly into the bloodstream (intravenous infusion).

Vyvgart is only available to patients who are on the Early Access to Medicines Scheme (EAMS). The scheme is not currently open to new patients.

In 2023, the Scottish Medicines Consortium (SMC) did not recommend Vyvgart for use on the NHS in Scotland. Read about the SMC’s assessment.

In January 2025, the National Institute for Health and Care Excellence (NICE) did not recommend Vyvgart for use on the NHS in England, Wales and Northern Ireland. While NICE acknowledged that Vyvgart can be beneficial, but they said there were too many gaps in the evidence to show that the treatment was cost-effective. Read about NICE’s assessment.

Argenx has submitted an appeal against the decision made by NICE. We have also supported an appeal from the charity myaware and leading myasthenia gravis clinical experts. An independent panel will meet on 6 May 2025 to discuss the appeal.

We worked in partnership with the charity myaware to make sure the experience and views of the myasthenia gravis community were heard throughout the NICE and SMC assessment process.

We also provided data to try to fill some of the evidence gaps NICE highlighted throughout the process. A key area was around the impact myasthenia gravis has on carers. We helped gather evidence to showcase this impact. We are pleased to see that NICE acknowledged the impact on carers when calculating the cost-effectiveness of efgartigimod in the final draft guidance.

We have supported an appeal by the charity myaware and leading myasthenia gravis clinical experts to NICE against its decision to not recommend NHS use of efgartigimod.

Evidence from the phase 3 ADAPT clinical trial was used in the UK assessment of Vyvgart. 167 participants, aged over 18 years old, with a myasthenia gravis activities of daily living (MG-ADL) score of at least five took part in the trial. The MG-ADL score measures the impact of the condition on a person’s daily function, such as talking, swallowing and getting up from a chair. The score can range from zero to 24, with a lower score means symptoms are less severe.

Participants were randomly assigned to receive Vyvgart (84 participants) or placebo (dummy drug, 83 participants). Each participant received at least one cycle as part of the trial. A cycle was defined as four infusions of either Vyvgart or placebo over four weeks. Vyvgart was found to be safe.

More participants who received Vyvgart showed improvements in the MG-ADL scale, compared to those who received the placebo. After the first cycle, 68% of participants who received Vyvgart had a reduction of at least two points, compared to 30% of participants who received the placebo. A reduction of two points is considered to be beneficial (clinically meaningful) to people living with the condition. This may mean people with the condition are able to complete daily tasks they were unable to before, such as brush their hair or get up out of a chair without assistance.

Long-term data, from the ADAPT+ trial, showed Vyvgart continued to show clinically meaningful improvements to the MG-ADL scale.

Last updated: 18/02/2025