FDA Approves Maribavir in Patients With Post-Transplant Cytomegalovirus Refractory to Antiviral Therapy

The FDA has approved maribavir for the treatment of adults and pediatric patients aged 12 years or older and weighing at least 35 kg with post-transplant cytomegalovirus infection/disease that is refractory to treatment with ganciclovir, valganciclovir, cidofovir, or foscarnet.

Officials with the FDA have approved maribavir (Livtencity, Takeda Pharmaceutical Company) for the treatment of adults and pediatric patients aged 12 years or older and weighing at least 35 kg with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet.

Although CMV is a rare disease, it is among the most common infections experienced by patients who have received transplants. Studies suggest the incidence rate of CMV in solid organ transplant recipients is between 16% to 56%, and the rate in hematopoietic stem cell transplant patients is 30% to 70%.

Additionally, CMV can lead to serious complications, including loss of the transplanted organ, failure of the graft, or loss of life. In patients with compromised immunity, the condition can result in clinically challenging and sometimes fatal complications.

“Today’s announcement redefines the management of post-transplant 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,” said Ramona Sequeira, president of the US Business Unit and Global Portfolio Commercialization at Takeda Pharmaceutical Company Limited, in a 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. We are grateful for the contributions of the patients and clinicians who participated in our clinical trials, as well as the dedication of our scientists and researchers.”

According to Takeda, maribavir is a new molecular entity which targets CMV at pUL97, resulting in inhibition of viral DNA replication, encapsidation, and nuclear egress. Compared to conventional antiviral therapies, more than twice the proportion of adult transplant patients with refractory or resistant CMV infection/disease achieved confirmed CMV DNA level <LLOQ (lower limit of quantification) at week 8 when treated with maribavir.

“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,” said Roy F. Chemaly, MD, MPH, FACP, FIDSA, of the Department of Infectious Diseases, Infection Control & Employee Health at The University of Texas MD Anderson Cancer Center, 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.”

REFERENCE

Takeda’s LIVTENCITY (maribavir) approved by U.S. FDA as the first and only treatment for people ages 12 and older with post-transplant cytomegalovirus (CMV), refractory (with or without genotypic resistance) to conventional antiviral therapies [news release]. Takeda; November 23, 2021. Accessed November 24, 2021. https://www.businesswire.com/news/home/20211123006185/en