FDA grants supplemental approval for Prevymis for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients at high risk
Merck Inc. known as MSD outside of the United States and Canada, announced the FDA has approved a new indication for Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor seropositive/Recipient CMV-seronegative [D+/R-]) following a priority review
Prevymis is an antiviral agent that was initially approved by the FDA in 2017 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). Prevymis is administered once-daily as an oral tablet or as an injection for intravenous infusion. Prevymis is contraindicated in patients receiving pimozide or ergot alkaloids. Increased pimozide concentrations due to concomitant administration of Prevymis may lead to QT prolongation and torsades de pointes. Increased ergot alkaloids concentrations due to concomitant administration of Prevymis may lead to ergotism. Prevymis is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.
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