FDA approves the first drug for treating resistant CMV
The first treatment for post-transplant Cytomegalovirus (CMV) has been approved by the US Food and Drug Administration (FDA). It is not incompatible with other medications. The treatment maribavir (Livtencity), is approved for children and adults 12 years and older who weigh at least 35 kilograms (77 pounds).
Globally, there are approximately 200,000 adult transplants each year. CMV, a type of herpes virus, is one of the most common infections in transplant patients, affecting 16 percent to 56% of solid organ transplant recipients and between 30 and 70 percent of hematopoietic stem cells transplant recipients according to Takeda Pharmaceutical Company Limited the company that manufactures Livtencity. For immunosuppressed transplant patients, CMV infection can lead to complications that can result in the loss of the transplanted or organ, or even death.
“Cytomegalovirus infections that are resistant or do not respond to treatment options are even more concerning,” John Farley, MD, MPH, the director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, said in an statement. “Today’s approval is a step towards meeting the need for a medical need that is not being met by providing a treatment option for the patients in this group.”
Orally, Livtencity acts by preventing the activity of the enzyme responsible for virus replication. The approval, which was announced on November 23, was based on the results of a clinical trial in phase 3 that compared Livtencity with conventional antiviral treatments in the pursuit of CMV DNA levels that were below those that are measured in patients who have received a transplant with CMV infection that is resistant or treatment-resistant. The press release says that 56% of 235 patients treated with Livtencity met the primary endpoint after 8 weeks. This is in contrast to 24% of those who received conventional antiviral treatments.
The most common adverse reactions associated with Livtencity included nausea, taste disturbances, diarrhea and vomiting.
Ramona Sequeira (President of Takeda’s US Business Unit, Global Portfolio Commercialization) said she was thankful for the contributions of clinicians and patients to our clinical trials. “People who undergo transplants go through a lengthy and complex healthcare journey. Now that we have the approval of this treatment, we’re thrilled to offer these individuals an oral antiviral that will combat CMV infection and disease.”
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