Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
FDA Approves Prevymis for Certain HSCT Recipients
Merck news release; 2017 Nov 9
The FDA has approved Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (allo-HSCT).
Indications: Prevymis is a CMV DNA terminase complex inhibitor indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive allo-HSCT recipients.
Dosage and administration: 480 mg administered once daily orally or as an intravenous infusion over 1 hour through 100 days post-transplant. If administered with cyclosporine, decrease dose to 240 mg once daily.
Efficacy and safety: Approval is based on results from a phase 3 trial showing that significantly fewer patients who took Prevymis (38%) developed clinically significant CMV infection, discontinued treatment, or had missing data through week 24 post-HSCT, vs those who received placebo (61%).
Side effects/risks: The most common adverse reactions are nausea, diarrhea, vomiting, peripheral edema, cough, headache, fatigue, and abdominal pain.
Merck receives FDA approval of Prevymis (letermovir) for prevention of cytomegalovirus (CMV) infection and disease in adult allogeneic stem cell transplant patients. [news release]. Kenilworth, NJ: Merck & Co, Inc. November 9, 2017. http://www.businesswire.com/news/home/20171109005397/en/Merck-Receives-FDA-Approval-PREVYMIS%E2%84%A2-letermovir-Prevention. Accessed November 13, 2017.
Prevymis [package insert]. Whitehouse Station, NJ: Merck & Co, Inc. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209939Orig1s000,209940Orig1s000lbl.pdf. Accessed November 13, 2017.