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.
Letermovir is an antiviral agent which targets the DNA terminal transferase complex of the cytomegalovirus (CMV) and which is used to prevent CMV reactivation in immunocompromised patients. Letermovir has been associated with mild-to-moderate serum aminotransferase elevations during therapy but has not been linked to cases of clinically apparent acute liver injury.
Letermovir is an orally bioavailable, non-nucleoside, 3,4-dihydroquinazolinyl acetic acid and inhibitor of the pUL56 subunit of the viral terminase complex of cytomegalovirus (CMV), with potential CMV-specific antiviral activity. Upon oral administration, letermovir binds to the pUL56 subunit of the viral terminase complex of CMV and prevents the cleavage of concatemeric DNA into monomeric genome length DNA. As this agent interferes with viral DNA processing and subsequent viral DNA packaging into procapsids, CMV replication is blocked and CMV infection is prevented.
Letermovir recieved approval from the FDA on November 8th, 2017 for use in prophylaxis of cytomegalovirus (CMV) infection in allogeneic hematopoietic stem cell transplant patients. It represents the first entry into a new class of CMV anti-infectives, DNA terminase complex inhibitors. Letermovir has recieved both priority and orphan drug status from the FDA. It is currently marketed under the brand name Prevymis.
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.
February 22, 2023
