Takeda announced today that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Livtencity (maribavir) for the treatment of post-transplant cytomegalovirus (CMV) infection/disease that is unresponsive to existing anti-CMV therapies. Livtencity is the first and only post-transplant anti-CMV medication approved in Japan that targets and inhibits the pUL97 kinase and its natural substrates.
This approval is largely based on the findings from the Phase 3 SOLSTICE trial (NCT02931539), which assessed the safety and efficacy of LIVTENCITY compared to alternative antiviral treatments in patients with CMV infection/disease that was resistant to prior therapies after undergoing hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT). Additionally, the Japanese Phase 3 open-label study (NCT05137717) contributed to the approval, focusing on patients with refractory CMV infection post-transplant.
In the SOLSTICE trial, maribavir (n=235) demonstrated a statistically significant improvement over alternative treatments (n=117) by the end of Week 8, specifically for the primary endpoint of confirmed CMV viremia clearance in post-transplant adults with refractory CMV infection. Among the 234 patients evaluated for safety, 60.3% (141 patients) experienced adverse reactions.
A separate open-label, multicenter, single-arm study evaluated the efficacy and safety of LIVTENCITY in Japanese post-transplant adults (41 randomized, including 3 with refractory CMV infection). The primary endpoint of CMV viremia clearance at the end of Week 8 was achieved in 33.3% of patients with refractory CMV infection. In this study, 36.6% (15 patients) experienced adverse reactions.
The TAK-620-303 (SOLSTICE) trial was a Phase 3 global, multicenter, randomized, open-label, active-controlled trial comparing the efficacy and safety of maribavir to investigator-assigned treatments (alternative antiviral therapies) in 352 HSCT and SOT recipients with CMV infections resistant to or refractory to treatments like ganciclovir, valganciclovir, foscarnet, or cidofovir. Patients underwent a 2-week screening period before being randomized 2:1 to maribavir (400 mg, twice daily) (n=235) or alternative treatments as determined by the investigator (n=117) for up to 8 weeks, followed by a 12-week follow-up phase. The primary efficacy endpoint was confirmed CMV viremia clearance at Week 8, with a key secondary endpoint of maintaining this clearance and controlling CMV infection symptoms through Week 16.
Livtencity (maribavir), taken orally as a tablet, is unique in that it targets and inhibits the CMV-specific UL97 protein kinase and its natural substrates. As of June 2024, LIVTENCITY has been approved in over 30 countries, including major markets such as Japan, the United States, Canada, Australia, the European Union, and China, for post-transplant CMV infections unresponsive to previous therapies.
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