EMA committee recommends approval of Merck’s Prevymis for prophylaxis of CMV disease in adult kidney transplant recipients at high risk

Merck, known as MSD outside of the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Prevymis (letermovir) for prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]). The CHMP has also recommended the approval for extending dosing for Prevymis from 100 days to 200 days following transplant in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT) who are at risk for late CMV infection and disease. The CHMP’s recommendations will now be reviewed by the European Commission for marketing authorization in the European Union (EU) and a final decision is expected this year.

“This positive CHMP opinion is an important step towards making Prevymis available to high-risk kidney transplant patients to help prevent CMV disease, as well as extending dosing to 200 days for adults who receive an allogeneic stem-cell transplant and are at risk for late CMV infection and disease,” said Dr. Elizabeth Rhee, vice president, global clinical development, Merck Research Laboratories. “CMV is a potentially serious viral infection for these high-risk transplant recipients, and we are pleased that these patients in the EU will soon be able to access Prevymis to help prevent CMV infection and disease.”

Prevymis is an antiviral agent that was initially approved by the US Food and Drug Administration (FDA) in 2017 and by the EMA in 2018 for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic HSCT. In June 2023, the FDA approved Prevymis for prophylaxis of CMV disease in adult kidney transplant recipients at high Risk, and in August 2023, the FDA approved extended 200-day dosing for Prevymis for CMV prophylaxis in HSCT recipients at risk for late CMV infection and disease.

The CHMP opinion for use of Prevymis for CMV disease prophylaxis in adult kidney transplant recipients was supported by a phase 3, randomized, multicenter, double-blind, active comparator-controlled non-inferiority trial (P002, NCT03443869) in 589 adult kidney transplant recipients at high risk (CMV D+/R-). Additionally, the efficacy of extending Prevymis prophylaxis from Week 14 (~100 days) through Week 28 (~200 days) post-HSCT in patients at risk for late CMV infection and disease was assessed in a multicenter, double-blind, placebo-controlled phase 3 trial (P040, NCT03930615) in adult CMV-seropositive recipients [R+] of an allogeneic HSCT.

Globally, many adults are CMV-seropositive [R+], meaning they have CMV antibodies in their blood, indicating a previous exposure to or primary infection with CMV. People with healthy immune systems rarely develop CMV symptoms after initial infection, with the virus typically remaining inactive or latent in the body for life. CMV-seropositive [R+] patients who undergo an HSCT are at high risk for CMV reactivation. CMV-seronegative recipients who receive an organ from a CMV-seropositive donor [D+/R-] are at high risk of CMV disease after transplantation.

Prevymis inhibits viral replication by targeting the CMV DNA terminase complex. Since 2017, PREVYMIS has been the only drug approved in the United States for prophylaxis of CMV infection and disease in adults who are CMV-seropositive [R+] and have received an allogeneic HSCT and has also been approved for this indication in more than 60 countries including EU member states, Canada, Japan and China. Prevymis is also approved in the United States for prophylaxis of CMV disease in adult kidney transplant recipients at high risk (Donor CMV-seropositive/Recipient CMV-seronegative [D+/R-]). Under an agreement signed in 2012, Merck (through a subsidiary) purchased worldwide rights to develop and commercialize letermovir from AiCuris GmbH & Co KG.

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