Uplizna
Authorised
This medicine is authorised for use in the European Union
inebilizumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Uplizna is a medicine used to treat adults with:
- neuromyelitis optica spectrum disorders (NMOSD), inflammatory disorders that affect mainly the optic nerve (which connects the eye to the brain) and the spinal cord. This leads to impaired vision, loss of sensation, loss of bladder control, weakness and paralysis of the arms and legs. The medicine is used in patients with antibodies against a protein called aquaporin-4 (AQP4).
- immunoglobulin G4 (IgG4)-related disease. IgG4-related disease is an autoimmune condition (a disease caused by the body’s own defence system attacking normal tissue) that can cause fibrosis (tissue scarring) and inflammation in one or multiple organs. It is used in people whose disease is active (causing symptoms and tissue damage).
Uplizna contains the active substance inebilizumab.
Treatment with Uplizna should be given under the supervision of a doctor experienced in treating NMOSD or active IgG4-related disease and who has access to medical support in case of serious reactions to the treatment. The medicine can only be obtained with a prescription.
Uplizna is available as a solution for infusion (drip) into the vein. Treatment starts with two infusions given two weeks apart and continues with one infusion every six months after that. Before treatment, patients should take corticosteroids and medicines to reduce fever. They should also be monitored during and one hour after the treatment for serious side effects related to the infusion. Vaccinations should be up to date and any infection should be well controlled before starting treatment with Uplizna.
For more information about using Uplizna, see the package leaflet or contact your doctor or pharmacist.
Inebilizumab is a monoclonal antibody (a type of protein) that attaches to immune cells called B cells and destroys them. In most people with NMOSD, B cells produce antibodies that attack AQP4, a protein involved in nerve cell function. In people with IgG4-related disease, B cells are involved in causing the fibrosis and inflammation. By reducing the numbers of B cells, the medicine is expected to reduce the symptoms of the condition being treated.
Uplizna was shown to be effective at reducing the risk of flare-ups of NMOSD or IgG4-related disease symptoms.
One main study, involving 230 adults with NMOSD, showed that of the patients with AQP4 antibodies, 18 out of 161 (11%) patients given Uplizna experienced a flare-up of symptoms over the course of 197 days compared with 22 out of 52 (42%) patients given placebo (a dummy treatment).
A second main study involved 135 adults with active IgG4-related disease. The study results showed that, during the course of 52 weeks, 7 out of 68 (10%) patients given Uplizna experienced a flare-up of symptoms compared with 40 out of 67 (60%) of those given placebo.
The most common side effects with Uplizna (which may affect more than 1 in 10 people) are urinary tract infections (infections of the structures that carry urine), inflammation and infections of the nose and throat, joint pain, back pain and lymphopenia (low levels of lymphocytes, a type of white blood cell).
Some side effects can be serious. The most frequent (which may affect more than 1 in 10 people) include infections.
Uplizna should not be used in patients with ongoing infections, including hepatitis B and tuberculosis, or who have had progressive multifocal leukoencephalopathy (a rare brain infection) in the past. It should also not be used by people with severely weakened immune systems or active cancers.
For the full list of side effects and restrictions of Uplizna, see the package leaflet.
Uplizna is effective at reducing NMOSD flare-ups in adults. The European Medicines Agency considered this to be a clinically important outcome in people with NMOSD as symptom flare-ups can cause serious, permanent disability.
Uplizna has also been found to be effective at reducing the risk of flare-ups in people with active IgG4-related disease.
Both NMOSD and IgG4-related disease are rare diseases and the medicine was therefore tested in small numbers of participants; however, the safety of the medicine was considered manageable. The Agency therefore decided that Uplizna’s benefits are greater than its risks and it can be authorised for use in the EU.
The company that markets Uplizna should provide a patient card to inform patients about the risk of infection with Uplizna, how to recognise symptoms of infections, including those of progressive multifocal leukoencephalopathy, and to seek medical attention if these arise.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Uplizna have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Uplizna are continuously monitored. Side effects reported with Uplizna are carefully evaluated and any necessary action taken to protect patients.
Uplinza received a marketing authorisation valid throughout the EU on 25 April 2022.
Product information
Latest procedure affecting product information:II/0012
10/11/2025
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
- Uplizna
- Active substance
- Inebilizumab
- International non-proprietary name (INN) or common name
- inebilizumab
- Therapeutic area (MeSH)
- Neuromyelitis Optica
- Anatomical therapeutic chemical (ATC) code
- L04AA
Pharmacotherapeutic group
ImmunosuppressantsTherapeutic indication
Uplizna is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive (see section 5.1).
News on Uplizna
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