Livtencity
Authorised
This medicine is authorised for use in the European Union
maribavir
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Livtencity is an antiviral medicine used to treat illness caused by cytomegalovirus (CMV) in adults who have had a haematopoietic stem cell transplant or an organ transplant. It is used in patients whose CMV illness has not responded to at least one other treatment, including ganciclovir, valganciclovir, cidofovir or foscarnet.
Haematopoietic stem cell transplantation involves using stem cells from a donor to replace the recipient’s bone marrow cells. The donated stem cells will form new bone marrow that produces healthy blood cells.
CMV is a common virus that usually only causes mild infection in healthy people. After infection, the virus remains in the body in an inactive form and does not cause harm. However, CMV can become active and cause illness in patients whose immune system (the body’s natural defences) is weakened, such as those who have had a stem cell or organ transplant.
CMV disease is rare, and Livtencity was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 18 December 2007 and 7 June 2013. Further information on the orphan designations can be found here: ema.europa.eu/medicines/human/orphan-designations/eu307519 and ema.europa.eu/en/medicines/human/orphan-designations/eu-3-13-1133.
Livtencity contains the active substance maribavir.
Livtencity can only be obtained with a prescription and should be used according to official recommendations. Treatment should be started by a doctor experienced in managing patients who have had a haematopoietic stem cell or organ transplant.
Livtencity is available as tablets to be taken by mouth and the recommended dose is 400 mg twice a day for 8 weeks. Treatment duration may be adjusted depending on the patient’s condition and response to treatment.
For more information about using Livtencity, see the package leaflet or contact your doctor or pharmacist.
Maribavir, the active substance in Livtencity, blocks an enzyme (a type of protein) from CMV called UL97 protein kinase, which the virus needs to multiply. This stops the virus from multiplying and infecting other cells.
Livtencity was found to be more effective than other available CMV treatment at clearing CMV infection in adults who had undergone a stem cell or organ transplant and whose CMV infection had not responded to prior treatment. In a main study involving 352 adults, 56% (131 out of 235) of patients treated with Livtencity had undetectable levels of CMV after 8 weeks compared with 24% (28 out of 117) of those who received another CMV treatment chosen by their doctor.
The most common side effects with Livtencity (which may affect more than 1 in 10 people) are taste disturbance, nausea (feeling sick), diarrhoea, vomiting and tiredness.
Serious side effects (which may affect more than 1 in 100 people) include diarrhoea, nausea, vomiting, weight loss, tiredness, and increased blood levels of immunosuppressant medicine (a medicine used to reduce activity of the immune system).
For the full list of side effects of Livtencity, see the package leaflet.
Livtencity must not be used together with ganciclovir or valganciclovir (other antiviral medicines).
For the full list of restrictions of Livtencity, see the package leaflet.
Livtencity was effective at clearing CMV from the blood, and its safety profile is acceptable and more favourable than available treatments. The European Medicines Agency therefore decided that Livtencity’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 Livtencity have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Livtencity are continuously monitored. Suspected side effects reported with Livtencity are carefully evaluated and any necessary action taken to protect patients.
Livtencity received a marketing authorisation valid throughout the EU on 9 November 2022.
Product information
Latest procedure affecting product information:
II/0008
21/03/2024
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
- Livtencity
- Active substance
- Maribavir
- International non-proprietary name (INN) or common name
- maribavir
- Therapeutic area (MeSH)
- Cytomegalovirus Infections
- Anatomical therapeutic chemical (ATC) code
- J05AX10
Pharmacotherapeutic group
Antivirals for systemic useTherapeutic indication
LIVTENCITY is indicated for the treatment of cytomegalovirus (CMV) infection and/or disease that are refractory (with or without resistance) to one or more prior therapies, including ganciclovir, valganciclovir, cidofovir or foscarnet in adult patients who have undergone a haematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).
Consideration should be given to official guidance on the appropriate use of antiviral agents.
News on Livtencity
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