Letermovir (Prevymis™) is an orally or intravenously administered cytomegalovirus (CMV) DNA terminase complex inhibitor being developed by Merck & Co., Inc., under a global license from AiCuris Anti-infective Cures GmbH. Letermovir has been approved in Canada and the USA for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic haematopoietic stem cell transplant (HSCT). In addition, letermovir has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, and is under review in several countries, including Japan. This article summarizes the milestones in the development of letermovir leading to its first global approval in Canada as well as the USA for the prophylaxis of CMV infection and disease in adult CMV-seropositive recipients of an allogeneic HSCT.
The preparation of this review was not supported by any external funding.
Compliance with Ethical Standards
Conflict of interest
During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Esther Kim is a salaried employee of Adis/Springer, is responsible for the article content and declares no relevant conflicts of interest.
Additional information about this Adis Drug Review can be found at http://www.medengine.com/Redeem/8BFCF060258EFDC2.
- 1.Centers for Disease Control and Prevention. Cytomegalovirus (CMV) and congenital CMV infection—for healthcare professionals: clinical overview. 2016. https://www.cdc.gov/. Accessed 1 Dec 2017.
- 2.Centers for Disease Control and Prevention. Cytomegalovirus (CMV) and congenital CMV infection: about CMV. 2016. https://www.cdc.gov/. Accessed 1 Dec 2017.
- 5.Merck. Merck receives FDA approval of PREVYMIS™ (letermovir) for prevention of cytomegalovirus (CMV) infection and disease in adult allogeneic stem cell transplant patients [media release]. 9 Nov 2017. http://www.mrknewsroom.com.
- 6.Merck Sharp & Dohme Corp. Prevymis™ (letermovir) tablet and injection: US Prescribing information. 2017. https://www.fda.gov. Accessed 1 Dec 2017.
- 7.US FDA. PREVYMIS™ (letermovir) tablet and injection: NDA approval letter. 2017. https://www.fda.gov. Accessed 1 Dec 2017.
- 8.Merck Canada Inc. Product monograph: PrevymisTM letermovir tablets. 2017. https://pdf.hres.ca/dpd_pm/00041967.PDF. Accessed 1 Dec 2017.
- 9.Adis Insight. Drug profile: letermovir. 2017. http://adis.springer.com/. Accessed 1 Dec 2017.
- 10.European Medicines Agency. CHMP summary of positive opinion for Prevymis. 2017. http://www.ema.europa.eu/ema/. Accessed 1 Dec 2017.
- 12.Merck. AiCuris and Merck enter exclusive worldwide license agreement for investigational portfolio targeting human cytomegalovirus [media release]. 15 Oct 2012. http://www.mrknewsroom.com/.
- 18.Wildum S, Zimmermann H, Lischka P. In vitro drug combination studies of Letermovir (AIC246, MK-8228) with approved anti-human cytomegalovirus (HCMV) and anti-HIV compounds in inhibition of HCMV and HIV replication. Antimicrob Agents Chemother. 2015;59(6):3140–8.CrossRefPubMedPubMedCentralGoogle Scholar
- 24.US National Library of Medicine. Clinicaltrials.gov. 2017. https://clinicaltrials.gov. Accessed 1 Dec 2017.