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Prevymis to focus on disease in high-risk adult kidney transplant recipients.
Merck & Co. has announced the FDA approval of Prevymis, a treatment for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk following a priority review. As an antiviral agent, it was initially approved in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).
“Prevymis has been an important addition to the care of high-risk adult CMV-seropositive patients who have received allogeneic stem cell transplants to help prevent CMV infection and disease. We are delighted that Prevymis is now approved to help prevent CMV disease in adult kidney transplant patients at high risk,” said Dr. Elizabeth Rhee, vice president, global clinical development, Merck Research Laboratories.
Reference: U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients. Merck. June 6, 2023. Accessed June 7, 2023. https://www.merck.com/news/u-s-fda-approves-new-indication-for-mercks-prevymis-letermovir-for-prevention-of-cytomegalovirus-cmv-disease-in-high-risk-adult-kidney-transplant-recipients/