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.
Market News and Data brought to you by Benzinga APIs
Posted In: BiotechNewsHealth CareFDAGeneralBriefsPhase 3 Trial
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!