Saturday, July 13, 2024

Cytomegalovirus Treatment: Takeda’s LIVTENCITY® Approved in Japan for Post-Transplant Infections

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Takeda has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved LIVTENCITY® (maribavir) for treating post-transplant cytomegalovirus (CMV) infection/disease refractory to existing anti-CMV therapies. LIVTENCITY is the first and only post-transplant anti-CMV treatment in Japan that targets and inhibits the pUL97 kinase.

Yasushi Kajii, Head of R&D Japan Region at Takeda, expressed satisfaction with the approval: “LIVTENCITY will provide the transplant community with a new option for post-transplant cytomegalovirus infection. CMV infection can lead to severe complications, including increased organ rejection and hospitalization rates. INTENSITY aims to address these challenges and transform the treatment landscape for patients in Japan.”

The approval is based on results from the Phase 3 SOLSTICE trial (NCT02931539) and a Japanese Phase 3 open-label study (NCT05137717). These studies evaluated LIVTENCITY’s safety and efficacy versus alternative antiviral treatments in patients with refractory cytomegalovirus infection post-hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).

Maribavir Shows Superior Efficacy in Cytomegalovirus Viremia Clearance

In the SOLSTICE trial, maribavir showed statistically significant improvement compared to alternative antiviral treatments for the primary endpoint of confirmed CMV viremia clearance at Week 8. Adverse reactions were observed in 60.3% of patients in the safety evaluation. The Japanese study demonstrated cytomegalovirus viremia clearance in 33.3% of patients with refractory CMV infection, with adverse reactions occurring in 36.6% of subjects.

LIVTENCITY, an orally administered anti-CMV compound, targets the CMV-specific UL97 protein kinase. It is approved in over 30 countries, including the US, Canada, Australia, the EU, and China. The drug is indicated for post-transplant CMV infection refractory to prior therapies, offering a new treatment option for patients facing these serious infections.

LIVTENCITY (maribavir) is administered orally at 400 mg twice daily for adults. It is not recommended for patients with CMV infection of the central nervous system or CMV retinitis. This drug is expected to cross the blood-brain barrier based on nonclinical studies but has low potential to enter the central nervous system. The approval provides a new solution for post-transplant patients with refractory cytomegalovirus infection.

Cytomegalovirus

SOLSTICE Trial Validates Maribavir’s Efficacy in Managing Refractory Cytomegalovirus Infections

The SOLSTICE trial (NCT02931539) was a Phase 3 global, multicenter, randomized, open-label, active-controlled trial. It assessed the efficacy and safety of maribavir compared to investigator-assigned alternative antiviral therapies in 352 HSCT and SOT recipients with CMV infections refractory to other antiviral therapies. The primary efficacy endpoint was confirmed cytomegalovirus viremia clearance at Week 8, with a key secondary endpoint of cytomegalovirus infection symptom control through Week 16.

CMV is a beta herpesvirus that commonly infects humans and may reactivate during immunosuppression. Serious disease can occur in individuals with compromised immune systems, including transplant recipients. Reactivation can lead to secondary infections and severe consequences, such as graft loss or death. The SOLSTICE trial supports LIVTENCITY’s role in managing these high-risk infections.

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Takeda is dedicated to creating better health outcomes for people worldwide through innovative treatments in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines. Guided by its commitment to patients, Takeda aims to improve patient experiences and advance new treatment options through a diverse pipeline. Headquartered in Japan, Takeda’s global team is driven by purpose and grounded in values that have defined the company for over two centuries.

 

Resource: Takeda, June 24, 2024

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