MedPath
EMA Approval

Livtencity

J05AX10

maribavir

Antivirals for systemic use

maribavir

Cytomegalovirus Infections

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.

Authorisations (1)

EMEA/H/C/005787

Takeda Pharmaceuticals International AG Ireland Branch,Block 2 Miesian Plaza,50-58 Baggot Street Lower,Dublin 2,Co Dublin,D02 HW68,Ireland

Authorised

November 9, 2022

Orphan Medicine

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.

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