FDA approves Merck's Premyvis letermovir for CMV

FDA approved once-daily oral and IV formulations of Prevymis letermovir (MK-8228) from Merck & Co. Inc. (NYSE:MRK) to prevent cytomegalovirus (CMV) infection in CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplantation (HSCT).

The approval was based on data from the Phase III MK-8228-001 trial in which Prevymis met the primary endpoint of reducing the proportion of patients with clinically significant CMV infection through week 24 post-HSCT vs. placebo (37.5% vs. 60.6%, p<0.0001) (see BioCentury, Mar. 2)...