FDA approves first and only treatment for Resistant Post-Transplant CMV

The approval brings a new therapeutic option to those living with this potential life-threatening opportunistic infection.

On Tuesday, the FDA granted approval of Livtencity (Maribavir) to Takeda Pharmaceuticals as the first treatment for post-transplant cytomegalovirus (CMV) that is resistant to other drugs. The treatment is approved for adults and children 12 years and older who weigh at least 35 kg. CMV is a type of herpes virus that commonly causes infection in patients after a stem cell or organ transplant. It can lead to serious complications, including loss of the transplanted organ or death. “Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population,” said John Farley, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research.

The drug’s safety and efficacy was evaluated in a Phase 3, multicenter, open-label, active-controlled trial that compared Livtencity with a treatment assigned by a researcher running the study, which could include one or two of the following antivirals used to treat CMV: ganciclovir, valganciclovir, foscarnet or cidofovir. Overall, 56% of the proportion of adult transplant recipients with refractory or resistant CMV infection/disease achieved confirmed CMV DNA level <LLOQ (lower limit of quantification) at Week 8 with Livtencity, compared to the 24% of those treated with conventional antiviral therapies. Livtencity is a new molecular entity which targets CMV at pUL97, resulting in inhibition of viral DNA replication, encapsidation and nuclear egress. It is Takeda’s second new molecular entity to receive FDA approval in this financial year.