MSD’s Prevymis has been green-lighted in the US to prevent cytomegalovirus infection and disease in at-risk adults who have received an allogeneic hematopoietic stem cell transplant (HSCT).
The US Food and Drug Administration has cleared Prevymis (letermovir) both as once-daily tablets for oral use and injection for intravenous infusion, specifically for adult CMV-seropositive recipients [R+] of an allogeneic HSCT.
CMV is a common and potentially serious viral infection in allogeneic HSCT recipients, which raises the risk of mortality.
Phase III data show that 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.
Also, all-cause mortality in patients receiving Prevymis was lower compared to placebo at 12 percent versus 17 percent, respectively, 24 weeks post-transplant.
“Our findings demonstrate that letermovir is a significant and welcomed advance in the prevention of clinically significant CMV infection and lowers mortality in this highly vulnerable patient population,” said Francisco Marty, associate professor of medicine at Harvard Medical School and attending physician in transplant and oncology infectious diseases at Dana-Farber Cancer Institute and Brigham and Women’s Hospital in Boston.
The drug was also recently recommended for approval by the European Medicines Agency’s Committee for Medicinal Products for Human Use.