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# Priority Review for Merck Prevymis sNDA
- URL: https://www.fdaweb.com/priority-review-for-merck-prevymis-snda/
- Published: 2023-02-17T12:00:00.000Z
- Updated: 2026-09-14T18:16:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153806

FDA has granted priority review for a Merck sNDA for its Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk. A company [statement](https://www.businesswire.com/news/home/20230217005097/en/U.S.-FDA-Accepts-for-Priority-Review-the-Supplemental-New-Drug-Application-for-Merck%E2%80%99s-PREVYMIS%E2%84%A2-for-Prophylaxis-of-Cytomegalovirus-Disease-in-Kidney-Transplant-Recipients-at-High-Risk?ref=fdaweb.com) says the PDUFA action date on the sNDA is 6/5.

FDA also accepted for review a second sNDA to extend the use of Prevymis from 100 days to 200 days in adults receiving an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease. The PDUFA action date for that sNDA is 9/7.

Prevymis is described as a first-in-class antiviral agent that was approved by FDA in 2017 and is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

Merck says the sNDA for using Prevymis in kidney transplant patients is supported by a Phase 3 trial that demonstrated non-inferior efficacy and a more favorable safety profile than Genentech’s Valcyte (valganciclovir), the current standard of care for CMV prophylaxis in kidney transplant patients.