Although valganciclovir is an effective CMV prophylactic agent after kidney transplantation, it is associated with significant side effects.
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Longer therapy with oral valganciclovir may modestly improve long-term developmental outcomes and hearing in neonates with symptomatic congenital cytomegalovirus (CMV) disease, reports a study in the New England Journal of Medicine.
For patients with glioblastoma, treatment with valganciclovir is associated with improved survival.
Letermovir is currently marketed under the brand name Prevymis for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic HSCT.
The new approvals include Besremi, Fyarro, Livtencity, Voxzogo, and Vuity.
Livtencity is an orally bioavailable anti-CMV compound that targets and inhibits the UL97 protein kinase and its natural substrates.
Maribavir is an orally bioavailable anti-CMV compound that targets and inhibits the UL97 protein kinase and its natural substrates.
The NDA submission is supported by data from the multicenter, randomized, open-label, active-controlled phase 3 TAK-620-303 (SOLSTICE) trial.
Foscarnet sodium injection is indicated to treat cytomegalovirus retinitis in patients with AIDS and acyclovir-resistant mucocutaneous HSV in immunocompromised patients.
Viracta Therapeutics announced that the FDA has granted Orphan Drug designation to nanatinostat (VRx-3996), in combination with valganciclovir, for the treatment of post-transplant lymphoproliferative disorder.