Takeda's CMV drug Livtencity receives FDA approval and sales are expected to reach US$800 million

CompilationFan Dongdong

Recently, the US FDA has approved Takeda Livtencity (maribavir) to treat patients with cytomegalovirus (CMV) infection after transplantation in adults or children 12 years of age or older

In a phase 3 trial, compared with the conventional antiviral treatment selected by doctors, the proportion of patients with undetectable CMV DNA in the blood after 8 weeks of Livtencity treatment more than doubled.

Livtencity has similar efficacy between solid organ transplants and hematopoietic cell transplants

Livtencity was approved through the priority review process and was previously granted Orphan Drug Designation (ODD) and Breakthrough Drug Designation (BTD) by the FDA

Another part of Livtencity's market opportunity lies in its potential to enter the first-line treatment of CMV infection after transplantation

Takeda’s next major regulatory milestone may come from the dengue vaccine candidate TAK-003

Reference source: Takeda's post-transplant CMV drug Livtencity, shouldering $800M in sales expectations, scores FDA nod