FDA Approves Prevymis for CMV Prevention in Kidney Transplant Patients

The FDA has approved a new indication for Merck’s Prevymis (letermovir) to prevent cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk. Prevymis is an antiviral agent that was initially approved by the FDA in 2017 to prevent CMV infection and disease in adult patients who have received allogeneic hematopoietic stem cell transplant. Prevymis is administered once-daily as an oral tablet or as an injection for intravenous infusion.

The retail price of Prevymis starts at $6,925.78 for 28 tablets of the 480 mg strength, according to GoodRx. Merck offers a coupon for privately insured patients to receive Prevymis at $15 per prescription for up to four prescriptions. Maximum savings is $2,500 per prescription.

Nicholas Kartsonis, M.D.

"Certain high-risk individuals who develop CMV infection following receipt of a kidney transplant are at increased risk for transplant failure and death. Prevymis has the potential to be an important new option with a favorable safety profile for patients at risk for CMV infection following a kidney transplant,” Nicholas Kartsonis, M.D., former senior vice president, vaccines and infectious diseases, at Merck Research Laboratories, said in a press release in February when the FDA accepted the application for priority review.

The FDA approval of the new indication was supported by a phase 3 non-inferiority trial in 589 adult kidney transplant recipients at high risk. The study demonstrated that Prevymis was non-inferior to Genentech’s Valcyte (valganciclovir), the current standard of care, for the primary endpoint of incidence of CMV disease through week 52 post-kidney transplant. The proportion of study participants with CMV disease through week 52 was 10% with Prevymis and 12% with valganciclovir. The incidence of CMV end organ disease was 2% vs less than 1%, respectively. Additionally, no patients in the Prevymis group experienced CMV disease through week 28 post-transplant (end of treatment period) compared with five patients in the valganciclovir group.

Adverse events (AEs) were those reported while participants were on study medication. Diarrhea was reported in at least 10% of participants in the Prevymis group and at a frequency greater than valganciclovir (Prevymis, 32%; valganciclovir, 29%). Study drug was discontinued due to an adverse events in 4% of Prevymis participants and 14% of valganciclovir participants