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Merck Gets Positive CHMP Opinion For Prevymis In EU - Quick Facts

Merck & Co. Inc. (MRK), known as MSD outside the U.S. and Canada, said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has adopted a positive opinion recommending approval of Prevymis (letermovir) for prophylaxis of cytomegalovirus or CMV reactivation and disease in adult CMV-seropositive recipients [R+] of an allogeneic haematopoietic stem cell transplant (HSCT).

The CHMP positive opinion will be considered by the European Commission. If the CHMP opinion is affirmed, the EC will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries of the European Union or EU, as well as European Economic Area members, Iceland, Liechtenstein and Norway.

Merck said it expects that the European Commission decision will be adopted within approximately two months.

In the pivotal Phase 3 clinical trial evaluating letermovir, significantly fewer patients in the Prevymis arm compared to the placebo arm developed clinically significant CMV infection, discontinued treatment or had missing data through Week 24 post-HSCT, the primary efficacy endpoint.

Prevymis was approved by the U.S. Food and Drug Administration or FDA on November 8. In the U.S., Prevymis is indicated for prophylaxis of cytomegalovirus infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant.

Merck also has filed letermovir for regulatory approval in other markets including Japan, where it is currently under review.

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