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Livtencity
Livtencity (maribavir) was approved for the following therapeutic use:
Treatment of adults with post-transplant cytomegalovirus (CMV) infection and disease resistant, refractory or intolerant to one or more prior therapies (see 4.3 Contraindications and, 4.4 Special warnings and precautions for use).
The antiviral activity of maribavir is mediated by competitive inhibition of the protein kinase activity of HCMV [human cytomegalovirus] enzyme UL97, which results in inhibition of the phosphorylation of proteins; an effect achieved at low concentrations of maribavir.
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Livtencity was considered favourable for the therapeutic use approved.