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

Prevymis (letermovir)

Indication:

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

Mechanism:

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.

Dosage:

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

Approval:

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).

Reference:

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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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.