Takeda's Maribavir Scores FDA Approval For Post-Transplant CMV Infection

The FDA has approved Takeda Pharmaceutical Co Ltd's TAK Livtencity (maribavir) for a common type of viral infection occurring in patients after organ transplant.

• The infection is caused by a type of herpes virus called cytomegalovirus (CMV). It can have a major negative impact on transplant recipients, including loss of the transplanted organ and death.
• The FDA said it approved Takeda's drug against CMV disease among patients who do not respond to available antiviral treatments.
• Livtencity works by preventing the activity of an enzyme involved in virus replication. The drug will be commercially available soon.
• Related Link: Takeda's Maribavir Hits Primary Endpoint Goal In Late-Stage Study In Transplant Recipients.
• Takeda is also investigating maribavir as the first-line treatment of CMV in hematopoietic stem cell transplant recipients in an ongoing Phase 3 trial.
• CMV is one of the most common post-transplant infections, with an estimated incidence rate of around 16%–56% and 30%–70% in solid organ and hematopoietic stem cell transplant recipients, respectively.
• Related content: Benzinga's Full FDA Calendar.
• Price Action: TAK shares are up 0.94% at $13.92 during the premarket session on the last check Wednesday.