Merck: FDA accepts for priority review sNDAs for PREVYMIS

Merck announced the U.S. FDA has accepted for review two supplemental new drug applications for PREVYMIS. The FDA granted priority review for the sNDA for PREVYMIS for prophylaxis of cytomegalovirus disease in adult kidney transplant recipients at high risk. The Prescription Drug User Fee Act, or target action date, is June 5. A second sNDA to extend use of PREVYMIS from 100 days to 200 days in adults receiving an allogeneic hematopoietic stem cell transplant who are at risk for late CMV infection and disease was also accepted for review, with a PDUFA date of Sept. 7.