FDA Accepts Two sNDAs for Merck’s Prevymis

The FDA has accepted for review two supplemental new drug applications (sNDAs) for Merck’s Prevymis (letermovir) for use with adult kidney transplant and stem cell transplant patients.

One of the sNDAs is for prophylaxis of cytomegalovirus disease, a common viral infection in adult kidney transplant recipients at high risk. The sNDA was granted Priority Review and has an anticipated decision date of June 5.

The second sNDA is to extend the use of Prevymis from 100 days to 200 days in adults receiving an allogeneic hematopoietic stem cell transplant who are at risk for late cytomegalovirus infection and disease. The FDA action date for this sNDA is Sept. 7.

Prevymis, an antiviral agent, was first FDA-approved in 2017 and is indicated for prophylaxis of cytomegalovirus infection and disease in adult cytomegalovirus-seropositive recipients of an allogeneic hematopoietic stem cell transplant.