(RxWiki News) The US Food and Drug Administration (FDA) has approved a treatment for a common type of post-transplant infection.
This new treatment is called Livtencity (maribavir). The FDA approved it to treat post-transplant cytomegalovirus (CMV) infections that do not respond to current antiviral treatments in patients who are 12 years old or older.
According to the FDA, this medication is the first approved post-transplant CMV drug.
“Transplant recipients are at a much greater risk for complications and death when faced with a cytomegalovirus infection,” said Dr. John Farley, director of the FDA’s Office of Infectious Diseases, in a press release. “Cytomegalovirus infections that are resistant or do not respond to available drugs are of even greater concern. Today’s approval helps meet a significant unmet medical need by providing a treatment option for this patient population.”
After organ or stem cell transplants, patients often deal with infections. CMV, a type of herpes virus, is a common type of post-transplant infection. This infection can lead to the loss of the transplanted organ. It can even be fatal.
Livtencity works to block the activity of human cytomegalovirus enzyme pUL97. This prevents the virus from replicating inside the body.
To test Livtencity for safety and effectiveness, researchers studied it in 352 patients who received transplants and developed a CMV infection that did not respond to current antiviral treatments. These patients received either Livtencity or another common antiviral drug used to fight CMV.
After eight weeks, 56 percent of patients who received Livtencity had no measurable amount of CMV in their bodies. For those who received the alternative treatments, that figure was only 24 percent.
Side effects of Livtencity included fatigue, nausea, vomiting, taste disturbance and diarrhea. The FDA noted that this drug can interact with similar antiviral drugs, and resistance to Livtencity can develop during and after treatment.
The FDA approved Livtencity for Takeda Pharmaceuticals Company Limited.