- For immediate release:
Today, the United States Food and Drug Administration approved Livtencity (maribavir) as the first drug for the treatment of adults and pediatric patients (aged 12 years and over and weighing at least 35 kilograms) with infection. / post-transplant cytomegalovirus (CMV) disease that does not respond (with or without genetic mutations causing resistance) to available antiviral therapy for CMV. Livetencity works by inhibiting the activity of the human cytomegalovirus pUL97 enzyme, thereby blocking the replication of the virus.
“Transplant recipients are at a much higher risk of complications and death when faced with cytomegalovirus infection,” said John Farley, MD, MPH, director of the Office of Infectious Diseases at the Center for Drug Evaluation and FDA Research. “Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Today’s approval addresses a significant unmet medical need by providing a treatment option for this patient population.
CMV is a type of herpes virus that commonly causes infection in patients after stem cell or organ transplants. CMV infection can lead to CMV disease and have a major negative impact on transplant recipients, including loss of the transplanted organ and death.
The safety and efficacy of Livtencity was evaluated in a phase 3, multicenter, open-label, active-controlled trial that compared Livtencity to a treatment assigned by a researcher conducting the study, which could include one or more two of the following antivirals used to treat CMV: ganciclovir, valganciclovir, foscarnet, or cidofovir. In the study, 352 transplant recipients with CMV infections who did not respond (with or without resistance) to treatment were randomly given Livtencity or investigator-assigned treatment for a period of up to eight. weeks.
The study compared the plasma CMV DNA concentration levels of the two groups at the end of the eighth week of the study, with efficacy defined as being below what is measurable. Of the 235 patients who received Livtencity, 56% had lower than measurable CMV DNA levels compared to 24% of the 117 patients who received investigator-assigned treatment.
The most common side effects of Livtencity include taste disturbance, nausea, diarrhea, vomiting, and fatigue. Livtencity may reduce the antiviral activity of ganciclovir and valganciclovir, therefore co-administration with these drugs is not recommended. Virologic failure due to resistance may occur during and after treatment with Livtencity. Therefore, CMV DNA levels should be monitored and resistance to Livtencity should be checked if the patient does not respond to treatment or relapses.
Livtencity has received Breakthrough Therapy and Priority Review designations for this indication. Designation of Breakthrough Therapy is a process designed to accelerate the development and review of drugs to treat severe disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on one or more criteria. clinically meaningful evaluation. The priority review designation directs the overall attention and resources to the assessment of drug claims that, if approved, would constitute significant improvements in the safety or effectiveness of treatment, diagnosis or prevention. of serious illnesses compared to standard requests.
The FDA has granted Livtencity approval to Takeda Pharmaceuticals Company Limited.
The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.