Takeda's Livtencity (Maribavir) Receives FDA Approval as First Therapy for Refractory Cytomegalovirus Infection in Transplant Patients

Today, the U.S. FDA announced the approval of Takeda's antiviral therapy Livtencity (maribavir) for marketing. It is indicated for the treatment of refractory cytomegalovirus (CMV) infection in adult or pediatric patients aged 12 years and older who have undergone hematopoietic stem cell transplantation (HSCT) or solid organ transplantation (SOT). These patients do not respond to existing antiviral therapies for CMV. The press release noted that this is the first approved therapy for this patient population.

CMV is a β-herpesvirus that infects humans and is one of the most common infections in transplant patients, with an estimated incidence of approximately 16-56% in solid organ transplant patients and about 30-70% in hematopoietic stem cell transplant patients. It increases the risk of illness in patients undergoing transplant surgery and may also heighten the risks of transplant rejection and opportunistic co-infections. Currently approved therapies not only have severe toxic side effects, but CMV has also developed resistance to them.

Livtencity blocks viral replication by inhibiting the pUL97 protein kinase of the CMV virus. It features a novel mechanism for suppressing CMV viral replication and offers improved safety compared to existing therapies. The U.S. FDA granted Livtencity Breakthrough Therapy Designation and Priority Review for the treatment of CMV infection and disease in transplant patients who are resistant or refractory to prior therapies.

The efficacy and safety of Livtencity are supported by an open-label, active-controlled Phase 3 clinical trial. In this trial, 352 patients with CMV infection received either Livtencity or other antiviral therapies chosen by the investigators. The trial results showed that after 8 weeks, 56% of the patients in the Livtencity group had undetectable levels of CMV DNA, compared to 24% in the active control group.

References:

[1] FDA Approves First Treatment for Common Type of Post-Transplant Infection that is Resistant to Other Drugs. Retrieved November 23, 2021, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-common-type-post-transplant-infection-resistant-other-drugs?utm_medium=email&utm_source=govdelivery

(Original text has been abridged)

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