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Livtencity FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 24, 2021.

FDA Approved: Yes (First approved November 23, 2021)
Brand name: Livtencity
Generic name: maribavir
Dosage form: Tablets
Company: Takeda Pharmaceutical Company Limited
Treatment for: CMV Infection in Transplant Patients

Livtencity (maribavir) is a cytomegalovirus (CMV) pUL97 kinase inhibitor used for the treatment of post-transplant CMV infection/disease.

  • Livtencity is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
  • CMV is a beta herpesvirus that is typically latent and asymptomatic in the body, but may reactivate during periods of immunosuppression. It can lead to serious disease in transplant patients who are receiving immunosuppressants, including loss of the transplanted organ and failure of the graft.
  • Livtencity is an antiviral agent that works by inhibiting human CMV replication.
  • Livtencity tablets are taken orally twice daily with or without food.
  • Common adverse reactions include taste disturbance, nausea, diarrhea, vomiting, and fatigue.

Development timeline for Livtencity

Nov 23, 2021Approval FDA Approves Livtencity (maribavir) for Post-Transplant Cytomegalovirus (CMV) Infection/Disease
Oct  7, 2021FDA Advisory Committee Recommends Use of Investigational Drug Maribavir (TAK-620) to Treat Post-Transplant Recipients with Cytomegalovirus (CMV) Infection and Disease Refractory to Treatment With or Without Resistance
May 21, 2021U.S. Food & Drug Administration Grants Priority Review of Maribavir for the Treatment of Post-Transplant Recipients With Cytomegalovirus Infection in Those Resistant and/or Refractory to Prior Anti-CMV Treatment
Jan  4, 2018Shire Receives FDA Breakthrough Therapy Designation for Maribavir, an Investigational Treatment for Cytomegalovirus (CMV) Infection in Transplant Patients

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.