FDA
FDA OKs letermovir for CMV prophylaxis in kidney transplant recipients
June 8, 2023

FDA has approved letermovir (Prevymis) for cytomegalovirus (CMV) prophylaxis in adult recipients of a CMV-seropositive kidney transplant. The new indication is based on results of a phase 3 clinical trial presented at the 2023 American Transplant Congress in San Diego, California and published in JAMA. Among adult CMV-seronegative kidney transplant recipients who received an organ from a CMV-seropositive donor, letermovir was noninferior to valganciclovir for prophylaxis of CMV disease over 52 weeks, with lower rates of leukopenia or neutropenia.
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