Takeda publishes Phase 3 Livtencity data in peer-reviewed journal

Takeda Pharmaceutical (TSE:4502/NYSE:TAK) has announced that it has published data from the SOLSTICE Phase 3 trial for Livtencity (maribavir) in post-transplant recipients with cytomegalovirus (CMV) infection in the peer-reviewed journal of Clinical Infectious Diseases.

The drug was statistically superior to conventional therapies at week 81. The trial met its primary endpoint. A total of 55.7% (131/235) of adult patients taking Livtencity achieved confirmed CMV DNA level under the lower limit of quantification.

It was also statistically significant to conventional therapies in a composite achievement of CMV DNA level less than the lower limit of quantification (LLOQ). In addition, the drug supported symptom control at week 8 with maintenance through week 161. The conventional therapies in the study included one or more of the antivirals ganciclovir, valganciclovir, foscarnet or cidofovir.

Last month, FDA approved Livtencity for use in patients at least …

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FDA approves novel treatment for post-transplant CMV infection 

FDA has approved Takeda Pharmaceutical’s (NYSE:TAK) Livtencity (maribavir) for use in patients at least 12 years old with post-transplant cytomegalovirus (CMV) infection or disease that does not respond to available antiviral therapy. The indication covers patients weighing at least 35 kilograms.

Livtencity blocks virus replication by blocking the activity of the human cytomegalovirus enzyme pUL97.

According to data gathered by Takeda, the infection is present in 16–56% of solid organ transplants and 30–70% of hematopoietic stem cell transplants.

CMV infections cause an increased risk of complications and death for transplant recipients, said Dr. John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern,” Farley said in a press release. “Today’s approval helps meet a significant unmet medic…

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