FDA Grants Priority Review to Prevymis to Prevent CMV After Kidney Transplants

The FDA has granted priority review for two supplemental new drug applications (sNDA) for Merck’s Prevymis (letermovir) to prevent cytomegalovirus (CMV) after transplants. The first is for adults who have had kidney transplants. The Prescription Drug User Fee Act (PDUFA) action date is June 5, 2023. A second sNDA is to extend the use of Prevymis from 100 days to 200 days in adults who have received an allogeneic hematopoietic stem cell transplant (HSCT) with a PDUFA date of Sept. 7, 2023.

CMV is a common virus. When a transplant recipient who is CMV-negative receives an organ from a donor who is CMV positive, the transplant recipient can get the infection from the donated organ. CMV disease can lead to end-organ damage, including gastrointestinal tract disease, pneumonia or retinitis. Transplant recipients who develop CMV infection are at increased risk for transplant failure and death.

Prevymis is an antiviral agent that was approved by the FDA in 2017 and is indicated to prevent CMV infection in adults after an allogeneic hematopoietic stem cell transplant. GoodRx shows retail prices for Prevymis start at about $6,590 for 28 tablets of the 480 mg. 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

“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., senior vice president, vaccines and infectious diseases, Global Clinical Development, Merck Research Laboratories, said in a press release.

The sNDA for use of Prevymis in kidney transplant recipients is supported by a phase 3 trial that demonstrated non-inferior efficacy and a more favorable safety profile compared with Genentech’s Valcyte (valganciclovir), the current standard of care for CMV prevention in kidney transplant recipients. Data from the trial were presented at the IDWeek Annual Meeting in October 2022. The incidence of leukopenia (decrease in white blood cells) and neutropenia (the most common type of white blood cell) was lower with Prevymis than with Valycyte.

Data supporting the use of Prevymis for 200 days for patients who have received hematopoietic stem cell transplant was from a phase 3 study. The trial met its primary endpoint and prevention with Prevymis to 200 days was superior to placebo in reducing the rate of clinically significant CMV infection from week 14 through week 28 post-transplant.