maribavir

FDA clears Takeda drug for post-transplant CMV infections

Takeda has scored the first-ever FDA approval of a treatment for refractory cytomegalovirus (CMV) infections in organ transplant patients, which can lead to an increased risk of complications and even death. Livtencity (maribavir) has been cleared for use in transplant patients aged 12 or over with CMV infections that do not respond to first-line treatment …

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Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients

Shots: The US FDA’s AMDAC voted to recommend the use of maribavir (TAK-620) to treat refractory CMV infection and disease with/out genotypic resistance to ganciclovir, valganciclovir, foscarnet, or cidofovir in transplant recipients The recommendations were based on the results from the P-II & III TAK-620-303 (SOLSTICE) trials of maribavir while the NDA submission of maribavir …

Takeda Receives the US FDA Advisory Committee’s Recommendation for TAK-620 (maribavir) to Treat CMV Infection in Post-Transplant Recipients Read More »

FDA panel backs Takeda’s CMV drug for transplant patients

Takeda is closing on a first FDA approval in the treatment of refractory cytomegalovirus (CMV) infections in organ transplant patients, after agency advisors voted unanimously in favour of its antiviral maribavir. Maribavir (TAK-620) should be approved for refractory CMV infections in people with solid organ transplants as well as haematopoietic stem cell transplants (HSCT), regardless …

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