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Key takeaways:
- Letermovir was first approved in 2017 for high-risk stem cell transplant recipients.
- CMV is relatively common in adults but is normally dormant.
The FDA on Tuesday approved letermovir for the prevention of cytomegalovirus disease in high-risk adult kidney transplant recipients, Merck announced.
The approval is for CMV-seronegative recipients of organs from CMV-seropositive donors.
The FDA approved Merck’s letermovir for prevention of CMV in adult kidney transplant recipients at high risk for infection.
Letermovir, marketed by Merck as Prevymis, was first approved by the FDA in 2017 for prevention of CMV infection and disease in adult CMV-seropositive patients receiving an allogeneic hematopoietic stem cell transplant (HSCT).
Although CMV is relatively common, the virus is normally kept dormant by a healthy immune system, according to the CDC. However, in people with weakened immune systems — such as those who have undergone an organ transplant and are on immunosuppressive therapy — the virus can be reactivated.
It is one of the most common post-transplant infections and can cause serious symptoms and even death in people with weakened immune systems.
“Prevymis has been an important addition to the care of high-risk adult CMV-seropositive patients who have received allogenic stem cell transplants to help prevent CMV infection and disease,” Elizabeth Rhee, MD, vice president for global clinical development at Merck Research Laboratories , said in a press release. “We are delighted that Prevymis is now approved to help prevent CMV disease in adult kidney transplant patients at high risk.”
The approval is based on data from a phase 3 randomized, multicenter, double-blind, active comparator-controlled noninferiority trial comparing letermovir with valganciclovir among 589 adult kidney transplant recipients.
The study randomly assigned participants in a 1:1 ratio to receive either letermovir and acyclovir (292) or valganciclovir with a placebo for acyclovir (297). Researchers monitored the patients for 52 weeks after transplant. After week 52, 10% of participants treated with letermovir had CMV disease compared with 12% of participants in the valganciclovir arm.
In February, the FDA also granted priority review for Merck’s application to increase use of letermovir from 100 days to 200 days for adults who receive an allogeneic HSCT and are at risk for CMV disease. The FDA is expected to announce a decision on that application in early September.
References:
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