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.
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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.
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.