Basic Information
J05AX10
maribavir
Antivirals for systemic use
Therapeutic 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.
Overview Summary
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.
Active Substances (1)
Maribavir
Documents (12)
Livtencity : Orphan maintenance assessment report (initial authorisation)
November 24, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Livtencity : EPAR - Public assessment report
November 24, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of opinion for Livtencity
September 16, 2022
CHANGES_SINCE_INITIAL_AUTHORISATION
Livtencity : EPAR - Public assessment report
November 24, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Livtencity : EPAR - Procedural steps taken and scientific information after authorisation
January 16, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Livtencity : Orphan maintenance assessment report (initial authorisation)
November 24, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
CHMP summary of opinion for Livtencity
September 16, 2022
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Livtencity : EPAR - Medicine Overview
November 24, 2022
OVERVIEW_DOCUMENT
Livtencity : EPAR - All authorised presentations
November 24, 2022
AUTHORISED_PRESENTATIONS
Livtencity : EPAR - Risk Management Plan
November 24, 2022
RISK_MANAGEMENT_PLAN_SUMMARY
Livtencity : EPAR - Product Information
November 24, 2022
DRUG_PRODUCT_INFORMATION
Livtencity-H-C-005787-P46-002 : EPAR - Assessment report
March 16, 2023
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
How is Livtencity used?
Answer
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.
Question
How does Livtencity work?
Answer
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.
Question
What benefits of Livtencity have been shown in studies?
Answer
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.
Question
What are the risks associated with Livtencity?
Answer
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.
Question
Why is Livtencity authorised in the EU?
Answer
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.
Question
What measures are being taken to ensure the safe and effective use of Livtencity?
Answer
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.
Question
Other information about Livtencity
Answer
Livtencity received a marketing authorisation valid throughout the EU on 9 November 2022.