EU approves Prevymis for cytomegalovirus after haematopoietic stem cell transplant.

Prevymis (letermovir) is indicated for the prevention of cytomegalovirus (CMV) reactivation and disease in prone adults who have received an allogeneic haematopoietic stem cell transplant (HSCT). The approval is based on Phase III data which shows significantly fewer patients taking the drug (38 percent) compared to those given a placebo (61 percent) developed clinically significant CMV infection, discontinued treatment or had missing data through Week 24 post-HSCT. In addition all-cause mortality in patients receiving Prevymis at 24 weeks post-transplant, was lower than placebo: 12 percent versus 17 percent, respectively.

Comment: letermovir was filed with the FDA in the summer of 2017 for cytomegalovirus. Competitors include Astellas Pharma/Vical's ASP 0113, Shire's maribavir and Chimerix's brincidofovir.