Merck Reports P-III Trial Results of Prevymis for the Prevention of Cytomegalovirus Disease in Adults After Kidney Transplantation
Shots:
- The P-III trial evaluates Prevymis (480md, qd) vs valganciclovir (900mg, qd within 7 days) in a ratio (1:1) in 601 adult kidney transplant recipients who are at high risk for CMV disease (D+/R-) through 28wks. post-transplant with follow-up through 52wks.
- The trial met its 1EPs i.e., Prevymis was effective & non-inferior to valganciclovir @52wks., (10.4% vs 11.8%) had CMV disease. In a pre-specified safety analysis, patients had less myelotoxicity (26.0% vs 64.0%), favorable safety profile & AEs lead to study drug discontinuations
- The company plans to submit an sNDA to the US FDA at the end of 2022. Prevymis was approved in the US for prophylaxis of CMV inf. and disease in adult CMV-seropositive recipients [R+] of an allogeneic HSCT
Ref: Merck | Image: Merck
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