FDA approves Livtencity as first treatment for cytomegalovirus infection after transplant
Takeda Pharmaceuticals Company Limited announced FDA approval of Livtencity as the first treatment for patients 12 years or older who weigh at least 35 kg and have cytomegalovirus infection after transplant that is refractory to treatment.
“Today’s announcement redefines the management of post-transplant cytomegalovirus (CMV) with the approval of the first and only treatment for transplant patients with CMV that is refractory with or without resistance, a significantly underserved and vulnerable patient community,” Ramona Sequeira, president of U.S. business unit and global portfolio commercialization at Takeda Pharmaceutical Company Limited, said in a company press release. “People undergoing transplants have a lengthy and complex health care journey; with the approval of this treatment, we’re proud to offer these individuals a new oral antiviral to fight CMV infection and disease.”
Livtencity (maribavir) was designed to prevent the activity of the cytomegalovirus enzyme, pUL97, and ultimately stop virus replication. A phase 3 trial confirmed the safety and efficacy of Livtencity before the FDA granted approval.
“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, MD, MPH, FACP, FIDSA, from the department of infectious diseases, infection control and employee health at The University of Texas MD Anderson Cancer Center in Houston, said in the press release. “In clinical studies, we observed Livtencity was statistically superior to conventional antiviral therapies in achieving the primary endpoint at week 8.”
Adverse effects of Livtencity include taste disturbance, nausea, diarrhea, vomiting and fatigue.