• 26 Jun 2024
• Admin
• News Article

Takeda Receives Japanese Approval for Livtencity for Post-Transplant CMV Infection/Disease

Overview

Takeda, a company focused on creating better health for people and a brighter future for the world, 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. Livtencity is the first and only post-transplant anti-CMV treatment approved in Japan that targets and inhibits pUL97 kinase and its natural substrates.

Words from R&D Divivsion: Takeda

• “We are pleased by the approval of Livtencity in Japan, which will provide the transplant community with a new option for treatment of post-transplant CMV infection in patients refractory to other therapies,” said Yasushi Kajii, head, R&D Japan Region at Takeda. 
• “A diagnosis of CMV infection can be particularly challenging for patients, and serious complications such as increased organ rejection and hospitalization rates can occur, when not successfully treated. We believe Livtencity has the potential to help address the challenges faced by people with post-transplant CMV and transform the treatment landscape for patients in Japan.”

Phase 3 SOLSTICE Trial

• The approval is primarily based on the results of the phase 3 SOLSTICE trial (NCT02931539), which evaluated the safety and efficacy of Livtencity versus alternative antiviral treatments for patients with CMV infection/disease refractory to prior therapies who underwent hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT), and the Japanese phase 3 open-label study in patients with CMV infection, including those with refractory CMV infection who underwent HSCT or SOT (NCT05137717).
• In the SOLSTICE trial (maribavir n=235, alternative treatments n=117), maribavir showed statistically significant improvement when compared to alternative antiviral treatments at the end of Week 8 for the primary endpoint of confirmed CMV viremia clearancea in post-transplant (HSCT or SOT) adults with refractory CMV infection. 
• Of the 234 patients included in the safety evaluation, adverse reactions (related cases) were observed in 141 patients (60.3%).

Primary Endpoint of CMV Viremia Clearance

• An open-label, multicenter, single-arm study was conducted to evaluate the efficacy and safety in Japanese patients in post-transplant (HSCT or SOT) adultsc (41 randomized, including 3 subjects with CMV infection refractory to the most recently administered anti-CMV agent). 
• The primary endpoint of CMV viremia clearanceb at the end of Study Week 8 was achieved in 33.3% of patients with refractory CMV infection. 
• Of 41 subjects included in the safety evaluation, adverse reactions (related events) were observed in 36.6% (15 subjects).

About Livtencity

• Livtencity (maribavir), an orally administered (tablet) anti-CMV compound, is the first and only antiviral agent that targets and inhibits the CMV-specific UL97 protein kinase and thus its natural substrates. 
• As of June 2024, Livtencity is approved in more than 30 countries for post-transplant CMV refractory to prior therapies, including such major markets as Japan, the United States, Canada, Australia, the European Union and China.

TAK-620-303 (SOLSTICE) Trial

• The TAK-620-303 (SOLSTICE) trial (NCT02931539, EudraCT 2015-004725-13) was a Phase 3 global, multicenter, randomized, open-label, active-controlled trial to assess the efficacy and safety of maribavir treatment compared to investigator-assigned treatment (alternative antiviral therapies) in 352 HSCT and SOT recipients with CMV infections that were refractory* or resistant to one or a combination of the alternative antiviral therapies: ganciclovir, valganciclovir, foscarnet, or cidofovir. 
• Adult patients underwent a 2-week screening period, followed by randomization 2:1 to maribavir (n=235) (400 mg, twice daily) or alternative antiviral treatments (n=117) (as dosed by the investigator) for up to 8 weeks. 
• After completion of the treatment period, subjects entered a 12-week follow-up phase. 
• The trial’s primary efficacy endpoint was confirmed CMV viremia clearance a at the end of Week 8. 
• The key secondary endpoint was confirmed CMV viremia clearance and CMV infection symptom control† at the end of Study Week 8 with maintenance of this treatment effect through Study Week 16.

CMV

• 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 infection can lead to secondary infections and serious consequences, including graft loss and, in extreme cases, can be fatal.

About Takeda

• Takeda is focused on creating better health for people and a brighter future for the world. 
• The company aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines.