FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Prevymis (letermovir)


Cytomegalovirus (CMV) prophylaxis in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT).


Antiviral agent against CMV. It inhibits the CMV DNA terminase complex (pUL51, pUL56, and pUL89), which is required for viral DNA processing, thereby interfering with virion maturation.


480 mg PO/IV once daily. Initiate between day 0 and day 28 posttransplantation (before or after engraftment) and continue through day 100.


Approval was based on a phase 3 clinical trial (n=565). In this study, significantly fewer patients developed clinically significant CMV infection in the letermovir group (38%, n=122/325) compared to the placebo group (61%, n=103/170). Additionally, fewer patients discontinued treatment or had missing data through week 24 post-HSCT (P<0.0001).


Marty FM, et al. Letermovir Prophylaxis for Cytomegalovirus in Hematopoietic-Cell Transplantation. N Engl J Med. 2017 Dec 21;377(25):2433-2444.


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