A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
Latest Information Update: 08 Jul 2024
At a glance
- Drugs Maribavir (Primary) ; Cidofovir; Foscarnet; Ganciclovir; Valganciclovir
- Indications Cytomegalovirus infections
- Focus Registrational; Therapeutic Use
- Acronyms SOLSTICE
- Sponsors Shire; Takeda; ViroPharma Incorporated
- 24 Jun 2024 According to Takeda media release, company announced that LIVTENCITY (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies on basis of NCT02931539 and NCT05137717 trial.
- 21 Dec 2023 According to a Takeda media release, based on results from this trial the LIVTENCITY (maribavir) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT) cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet.
- 28 Jul 2023 Results (n=350) of a drug resistance analysis of maribavir therapy for refractory or resistant cytomegalovirus infection in transplant recipients published in the Journal of Infectious Diseases