Merck’s Prevymis (letermovir) Receives the US FDA’s Approval for Prevention of Cytomegalovirus Disease
- The US FDA has approved Prevymis for prophylaxis of CMV disease in adult kidney transplant recipients who are at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-])
- The approval was based on the P-III trial of Prevymis vs valganciclovir in a ratio (1:1) in 601 patients which showed that Prevymis was non-inferior to valganciclovir for 1EPs of incidence of CMV disease @52wk. post-kidney transplant, patients with CMV disease (10% vs 12%), efficacy was comparable across all subgroups
- AEs leading to treatment discontinuation (4% vs 14%). Prevymis was approved in the US for prophylaxis of CMV inf. & in adults who are CMV-seropositive [R+] & received an allogeneic HSCT; approved in 60+ countries incl. EU member states, Canada, Japan & China
Ref: Merck | Image: Merck
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