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 12 years old with post-transplant CMV infection or disease that does not respond to available antiviral therapy. The indication is limited to patients weighing at least 35 kilograms.
“As we continue to study maribavir, we remain steadfast in our research to provide physicians and patients with a treatment that potentially redefines post-transplant CMV,” said Dr. Obi Umeh, vice president and maribavir global program leader at Takeda.
Earlier, FDA granted the drug Orphan Drug Designation and Breakthrough Therapy Designation to maribavir.
Cambridge, Mass.–based Takeda announced that Livtencity was available for individuals covered by the FDA approval.
Filed Under: clinical trials, Drug Discovery
