The U.S. Food and Drug Administration (FDA) approved Livtencity (maribavir) from Takeda Pharmaceutical Company for adults and children 12 years of age and older. Who weigh at least 35 kilograms with post-transplant cytomegalovirus (CMV) infection and are resistant to various other antiviral medications, including ganciclovir, valganciclovir, cidofovir, or foscarnet.

The post-transplant drug is an orally bioavailable anti-CMV compound, a new molecular entity

The FDA’s Advisory Committee unanimously recommended approval of the drug on October 7, based on data from Phase II and III clinical trials.

The drug is an orally bioavailable anti-CMV compound, a new molecular entity. Antiviral, it targets and inhibits UL97 protein kinase and its natural substrates. The FDA granted it Orphan Drug and Breakthrough Therapy designation. It also received Orphan Drug Designation from the European Commission.

CMV is a beta herpesvirus. The data suggest that between 40% and 100% of adult populations have evidence of prior infection.

It is usually latent and asymptomatic in the body, but it reactivates if a person becomes immunosuppressed. As a result, in people with compromised immune systems, such as people with various types of transplants and serious illnesses, infection can occur.

CMV is one of the most common viral infections in transplant recipients

Out of approximately 200,000 adult transplants each year worldwide, CMV is one of the most common viral infections in transplant recipients. The occurrence rate is 15% to 56% in solid organ transplant recipients and 30% to 70% in hematopoietic stem cell transplant recipients.

In these patients, CMV infection can be severe, often fatal, causing loss of the transplanted organ.

“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 US Business Unit Marketing and Global Portfolio, Takeda.

“People who undergo transplants have a long and complex healthcare journey. With the approval of this treatment, we are proud to offer these individuals a new oral antiviral to combat CMV infection and disease. We are grateful for the contributions of the patients and physicians who participated in our clinical trials. As well as for the dedication of our scientists and researchers ”.

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Takeda is also evaluating the drug as a first-line treatment for CMV in hematopoietic stem cell transplant (HSCT) recipients. It is currently in a phase III trial.

The most common side effects

The drug was studied in the TAK-620-303 (SOLSTICE) trial. 352 adult patients with HSCT and solid organ transplantation (SOT) participated in it. With refractory CMV infection, with or without resistance, to one or a combination of the antiviral drugs mentioned above. They were randomly chosen 2: 1 to receive maribavir twice daily or an investigator-assigned treatment (IAT), one of the antivirals, for up to eight weeks.

After the end of the treatment period, the patients were followed for 12 weeks. The primary efficacy endpoint was the COBAS AmpliPrep / COBAS TaqMan CMV Assay confirmed CMV DNA level at the end of Week 8.

Livtencity was statistically superior to conventional antiviral therapies

The most common side effects in all grades were taste problems, nausea, diarrhea, vomiting, and fatigue. A higher percentage of patients in the IAT group discontinued the trial due to adverse events than the Livtencity group, 32% and 13%, respectively.

“The FDA approval of Livtencity marks a major step forward in the treatment of post-transplant CMV, providing a new treatment option for those living with this potentially life-threatening opportunistic infection,” said Roy F. Chemaly, MD, Department of Infectious Diseases, Infection Control and Employee Health at the University of Texas MD Anderson Cancer Center in Houston, TX.

“In clinical studies, we observed that Livtencity was statistically superior to conventional antiviral therapies in achieving the primary endpoint at week 8.”

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