默沙东普瑞明两种剂型获批新增200天剂量方案

Core Viewpoint - Merck has received approval from the NMPA for a new 200-day dosing regimen of its non-nucleoside CMV inhibitor, Prevymis® (Letermovir), for adult patients at risk of late-onset CMV infection and disease following HSCT, extending the previous 100-day regimen [1][2]. Group 1: Product Approval and Implications - The new dosing regimen allows for the continued use of Prevymis® up to 200 days post-HSCT for adults, providing extended protection against CMV infection [1]. - Prevymis® was previously approved for use in CMV-seropositive adults and children over 6 months old, with a 100-day treatment duration post-HSCT [1]. - The approval of the 200-day regimen is expected to enhance clinical practices and support personalized CMV prevention strategies for patients [1]. Group 2: Industry Impact and Expert Opinions - CMV infection is a major complication for HSCT recipients, contributing to increased mortality rates associated with transplant procedures [2]. - The new 200-day regimen addresses a gap in CMV prevention management beyond the initial 100 days, offering a longer window of protection during immune reconstitution for adult patients [2]. - Merck's advancements in the anti-infective field are highlighted by the approval for extending the use of Prevymis® for both adult patients at risk and future approvals for pediatric patients [2].