CMV

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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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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Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection

Shots: The P-III TAK-620-303 (SOLSTICE) trial involves assessing TAK-620 (400mg) vs conventional antiviral therapies (IAT) in HCT and SOT recipients in a ratio (2:1) with R/R CMV infection refractory with/ out resistance, to one or a combination of the conventional antiviral therapies The 1EPs study shows confirmed CMV viremia clearance @ 8wk; (55% vs 26.1% …

Takeda Report Results of TAK-620 (maribavir) in P-III SOLCTICE Trial for the Treatment of Post-Transplant Patients with Cytomegalovirus Infection Read More »