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FDA Approves Letermovir for CMV Prophylaxis Post-Transplantation

Silas Inman @silasinman
Published: Thursday, Nov 09, 2017

Dr. Roy Baynes

Roy Baynes, MD, PhD
The FDA has approved letermovir (Prevymis) to prevent cytomegalovirus (CMV) infection in adult CMV-seropositive patients treated with an allogeneic hematopoietic stem cell transplant (HSCT), based on a significant reduction in CMV infection rates in a phase III study.

Letermovir is a non-nucleoside CMV inhibitor that targets the viral terminase complex to prevent replication. Merck plans to make the medication available in December 2017 at a list price of 5.00 for a tablet version and 0.00 for an injection formulation.
Marty FM, Ljungman PT, Chemaly RF, et al. A Phase III Randomized, Double-Blind, Placebo-Controlled Trial of Letermovir (LET) for Prevention of Cytomegalovirus (CMV) Infection in Adult CMV-Seropositive Recipients of Allogeneic Hematopoietic Cell Transplantation (HCT). Presented at: BMT Tandem Meetings; February 23-26, 2017; Orlando, Florida.

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