Merck’s Prevymis (letermovir) Receives the US FDA’s Approval for Prevention of Cytomegalovirus Disease
Shots:
- 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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
