FDA Approves Treatment for Post-Transplant Infection

The FDA has approved Livtencity (maribavir) as the first drug for treating patients 12 years of age and older with post-transplant cytomegalovirus (CMV) infection. Developed by Takeda Pharmaceutical company, Livtencity is a new molecular entity that works by preventing the activity of human cytomegalovirus enzyme pUL97, which blocks virus replication.

Roy F. Chemaly, M.D,

“The FDA approval of Livtencity marks a major step forward in the treatment of post-transplant CMV, bringing a new therapeutic option to those living with this potential life-threatening opportunistic infection,” Roy F. Chemaly, M.D., department of infectious diseases, Infection Control & Employee Health at The University of Texas MD Anderson Cancer Center in Houston, said in a statement.

The phase 3 SOLSTICE study evaluated 352 transplant recipients with CMV infections who did not respond to treatment randomly received Livtencity or treatment assigned by a researcher for up to eight weeks.

Of the 235 patients who received Livtencity, 56% had levels of CMV DNA concentration levels below what was measurable versus 24% of the 117 patients who received an investigator-assigned treatment.

The most common side effects of Livtencity include taste disturbance, nausea, diarrhea, vomiting and fatigue.

CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16% to 56% in solid organ transplants and 30% to 70% in hematopoietic stem cell transplants.