Takeda's CMV drug Livtencity misses Phase III goal

Japan’s largest drugmaker Takeda (TYO: 4502) on Monday announced that in the AURORA trial, a Phase III, multicenter, randomized, double-blind, double-dummy, active-controlled study to assess the efficacy and safety of Livtencity (maribavir) compared to valganciclovir for the treatment of cytomegalovirus (CMV) infection in hematopoietic stem cell transplant (HSCT) recipients, maribavir demonstrated clinically-meaningful efficacy in confirmed CMV viremia clearance.

However, it did not meet its primary endpoint of non-inferiority versus valganciclovir (maribavir 69.6% [190/273] versus valganciclovir 77.4% [212/274]; adjusted difference, -7.7%; 95% CI: -14.98, -0.36), based on the prespecified non-inferiority margin of 7%.

Livtencity, which has already won regulatory approval for CMV in Europe, the USA, Canada and Australia, is already generating “promising” sales following a US launch in December 2021, the company noted along with recent financial results. Takeda has projected $700 million to $800 million in peak sales for Livtencity.