Imaavy
Authorised
This medicine is authorised for use in the European Union
nipocalimab
MedicineHumanAuthorised
On Monday, 12 January 2026, between 07:00 and 10:00 CET (Amsterdam time), this website will be unavailable due to scheduled maintenance.
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Imaavy is a medicine to treat adults and adolescents aged 12 years and older with generalised myasthenia gravis, an autoimmune disease in which the immune system (the body’s natural defences) disrupts communication between nerves and muscles, causing muscle weakness and tiredness.
Imaavy is used in patients whose immune system abnormally produces antibodies against acetylcholine receptors (AChR) or muscle-specific tyrosine kinase (MuSK), proteins found on muscle cells. It is used in addition to standard treatment for myasthenia gravis.
Imaavy contains the active substance nipocalimab.
Imaavy can only be obtained with a prescription. Treatment should be given and supervised by a doctor experienced in treating disorders that affect muscles and nerves.
Imaavy is given as an infusion (drip) into a vein every 2 weeks. The first infusion lasts about 30 minutes, and subsequent ones about 15 minutes. Patients should be monitored for 30 minutes after each infusion in case an infusion-related or allergic reaction occur.
For more information about using Imaavy, see the package leaflet or contact your doctor or pharmacist.
In myasthenia gravis, the immune system produces immunoglobulin G (IgG) antibodies (a type of protein) that target proteins involved in the communication between nerves and muscles, such as AChR and MuSK.
The active substance in Imaavy, nipocalimab, is a monoclonal antibody that attaches to neonatal Fc receptor (FcRn), a protein that normally protects IgG antibodies from being broken down.
By binding to and blocking FcRn, nipocalimab increases the removal of IgG antibodies, including those targeting AChR and MuSK, thereby lowering their levels and preventing them from disrupting AChR or MusK. This is expected to lead to an improvement in muscle function.
A main study showed that Imaavy is effective in treating adults with generalised myasthenia gravis. This study involved 153 participants who had antibodies against AChR or MuSK and for whom standard of care (standard treatment) was not sufficient. Participants were either given Imaavy in addition to standard of care or placebo (a dummy treatment) with standard of care.
The study looked at the effect of treatment using the myasthenia gravis‑specific activities of daily living (MG‑ADL) scale which measures the impact of the disease on patients’ daily activities. The score ranges from 0 to 24 with higher scores indicating more severe symptoms.
After 24 weeks of treatment, patients given Imaavy had an average reduction of 4.7 points in their MG-ADL score, compared with an average reduction of 3.3 points for those given placebo.
A supportive study involved 8 adolescents aged 12 to 17 years and showed that Imaavy behaves in the body of adolescents and adults in a comparable way. It is therefore expected that the medicine has comparable effects in both age groups.
For the full list of side effects and restrictions with Imaavy, see the package leaflet.
The most common side effects with Imaavy (which may affect more than 1 in 10 people) include muscle spasms, peripheral oedema (swelling usually affecting arms and legs), increased lipids (fats) and decreased serum albumin (a blood protein).
At the time of approval, there was a need for additional treatment options for people with generalised myasthenia gravis. The need was even greater for adolescents for which treatment options were very limited, and patients with antibodies against MuSK who often have more severe symptoms and fewer treatment options.
Data assessed show that, when given in addition to standard treatments, Imaavy is effective in patients aged 12 years and older with generalised myasthenia gravis who have antibodies against AChR or MuSK. It helps relieve symptoms of the disease and is expected to reduce the risk of the disease worsening.
Regarding safety, the Agency identified that treatment with Imaavy often led to an increase in blood levels of lipids (fats). Over time, higher levels of blood lipids can potentially affect the heart and blood vessels. As treatment with Imaavy is intended to be long term and may be started at a young age, measures have been put in place to minimise these risks. In addition, a study will further assess the impact of long-term treatment.
The European Medicines Agency therefore decided that Imaavy’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imaavy have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Imaavy are continuously monitored. Suspected side effects reported with Imaavy are carefully evaluated and any necessary action taken to protect patients.
Imaavy received a marketing authorisation valid throughout the EU on 28 November 2025.
Product information
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Imaavy
- Active substance
- nipocalimab
- International non-proprietary name (INN) or common name
- nipocalimab
- Therapeutic area (MeSH)
- Myasthenia Gravis
- Anatomical therapeutic chemical (ATC) code
- L04AL03
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Imaavy is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti‑acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
News on Imaavy
This page was last updated on