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FDA Approves Treatment for Post-Transplant Infection
Livtencity is the first therapy approved to treat cytomegalovirus infection, which is common after transplants.
The FDA has approved Livtencity (maribavir) as the first drug for treating patients 12 years of age and older with post-transplant cytomegalovirus (CMV) infection. Developed by Takeda Pharmaceutical company, Livtencity is a new molecular entity that works by preventing the activity of human cytomegalovirus enzyme pUL97, which blocks virus replication.
Roy F. Chemaly, M.D,
“The FDA approval of Livtencity marks a major step forward in the treatment of post-transplant CMV, bringing a new therapeutic option to those living with this potential life-threatening opportunistic infection,” Roy F. Chemaly, M.D., department of infectious diseases, Infection Control & Employee Health at The University of Texas MD Anderson Cancer Center in Houston, said in a statement.
The phase 3 SOLSTICE study evaluated 352 transplant recipients with CMV infections who did not respond to treatment randomly received Livtencity or treatment assigned by a researcher for up to eight weeks.
Of the 235 patients who received Livtencity, 56% had levels of CMV DNA concentration levels below what was measurable versus 24% of the 117 patients who received an investigator-assigned treatment.
The most common side effects of Livtencity include taste disturbance, nausea, diarrhea, vomiting and fatigue.
CMV is one of the most common infections experienced by transplant recipients, with an estimated incidence rate of around 16% to 56% in solid organ transplants and 30% to 70% in hematopoietic stem cell transplants.
FDA Issues Complete Response Letter for Pz-Cel to Treat Epidermolysis Bullosa
April 22nd 2024Prademagene zamikeracel is a cell therapy designed to incorporate the functional collagen-producing COL7A1 gene into a patient’s own skin cells. The FDA is asking for additional information on manufacturing practices.
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In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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FDA Approves Stelara Biosimilar, Selarsdi
April 18th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
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