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Rystiggo

Rystiggo (also known as rozanolixizumab) is a potential treatment for adults with myasthenia gravis who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Pharmaceutical company: UCB Pharma Ltd

About the treatment

To move, signals must be sent from the brain, down specialised cells called nerves to the muscle. Acetylcholine receptors and a protein called MuSK play a key role in passing the signal from nerve cells to the muscle. In myasthenia gravis, the immune system attacks the acetylcholine receptors, and in a smaller percentage of cases, the MuSK protein. This means the nerve cells struggle to send strong signals to muscles, leading to muscle weakness.

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

Rystiggo come as a liquid and is administered slowly under the skin (subcutaneous infusion).

Can I (or my child) get access now?

Rystiggo may be available through an early access scheme. For more information, please get in touch with your clinician.

Current status
Can it be prescribed in the UK? Yes
Is it available through the NHS? England: No – assessment in progress
Wales: No – assessment in progress
Northern Ireland: No – assessment in progress
Scotland: No

 

UCB Pharma have told the SMC they plan to apply in the future. More information on the SMC’s assessment can be found on their website.

Our involvement

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

This has included:

  • nominating and supporting members of the community to share their experience of myasthenia gravis
  • providing feedback on the draft guidance
Clinical trial results

Rystiggo was tested in the phase 3 MycarinG trial. 200 participants, aged over 18 years old, with a myasthenia gravis activities of daily living (MG-ADL) score of at least three 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 one of two doses of Rystiggo (133 participants) or placebo (dummy drug, 67 participants). All participants tested positive for the antibodies which attack acetylcholine receptors or MuSK protein. Rystiggo was found to be safe. After 43 days, more participants who received Rystiggo showed improvements in the MG-ADL scale, compared to those who received the placebo.

68% of participants who received Rystiggo had a reduction of at least two points, compared to 28% 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.

Last updated: 18/02/2025

Support and information

Myasthenia gravis

Myasthenia gravis (sometimes abbreviated to MG) is a chronic, autoimmune condition that causes muscle weakness and excessive muscle fatigue. It is rare, affecting about 15 in every 100,000 people in the UK.

Research

We fund groundbreaking research to learn more about muscle wasting conditions and lead us to new treatments. We’ve already made advances that would have been unthinkable just 10 years ago, and we are determined to go even further and faster.

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