The European Commission ( EC ) has granted marketing authorization for Livtencity ( Maribavir ) 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 ).
Livtencity is the first oral treatment that inhibits CMV-specific UL97 protein kinase and its natural substrates.
The authorization was based on the phase 3 SOLSTICE trial, which evaluated the safety and efficacy of Maribavir versus conventional antiviral therapies ( Ganciclovir, Valganciclovir, Cidofovir or Foscarnet ) for the treatment of adult HSCT and SOT recipients with CMV infection refractory ( with or without resistance ) to prior therapies.
CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40-100% of various adult populations.
CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression.
Serious disease may occur in individuals with compromised immune systems, which includes patients who receive immunosuppressants associated with various types of transplants including HSCT or SOT.
Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16-56% in SOT recipients and 30-80% in HSCT recipients.
In transplant recipients, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and, in extreme cases, can be fatal.
Existing therapies to treat post-transplant CMV infections may demonstrate serious side effects that require dose adjustments or may fail to adequately suppress viral replication. Additionally, existing therapies may require or prolong hospitalization due to administration. ( Xagena )
Source: FDA, 2022