Merck, known as MSD outside the US and Canada, has announced that Health Canada has approved a new indication for PREVYMIS (letermovir) to prevent cytomegalovirus (CMV) disease in high-risk adult kidney transplant recipients. This significant approval specifically applies to cases where the donor is CMV-seropositive or the recipient is CMV-seronegative (D+/R-), addressing a crucial need in transplant medicine.
The approval by Health Canada is based on the robust results of Phase III, a double-blind, multicenter, randomized, active comparator-controlled non-inferiority trial, identified as P002 (NCT03443869). This comprehensive trial included 589 adult kidney transplant recipients who were identified as high-risk (CMV D+/R-). The rigorous design and large sample size of this study provide a solid foundation for the new indication.
In the Phase III trial, participants were randomized in a one-to-one ratio to receive either PREVYMIS alongside acyclovir (n=292) or valganciclovir with a placebo to acyclovir (n=297). The study medication was initiated between Day 0 and Day 7 following the kidney transplant and continued through Week 28, which is approximately 200 days post-transplant. Importantly, PREVYMIS was administered either orally or intravenously, with the dosage remaining consistent regardless of the administration route, demonstrating the flexibility of this treatment.
Merck’s PREVYMIS Gains Health Canada Approval for Cytomegalovirus Prevention in High-Risk Kidney Transplant Patients
Philippe Houle, Executive Director of Infectious Diseases and Specialty Medicines at Merck Canada, expressed the company’s enthusiasm, stating, “We are pleased that PREVYMIS has received Health Canada approval to help prevent cytomegalovirus disease in high-risk adult kidney transplant patients. Our focus remains solely on providing innovative medicines to address the unmet needs of all Canadians. This approval underscores our commitment to advancing patient care and delivering critical therapeutic options to those in need.”
PREVYMIS is a potent antiviral agent that was initially approved by the US Food and Drug Administration (FDA) in 2017 for the prophylaxis of cytomegalovirus infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT). It is designed to be taken once daily, either as an oral tablet or as an injection for intravenous infusion, offering convenience and adaptability in clinical use.
In June 2023, Merck received FDA approval for PREVYMIS for the same indication of cytomegalovirus disease prophylaxis in adult kidney transplant recipients at high risk, following a priority review. This approval was based on the same Phase III trial data, highlighting the global impact of this crucial study.
Health Canada Approval of PREVYMIS Expands Cytomegalovirus Prevention for High-Risk Kidney Transplant Patients
The Health Canada approval marks a pivotal step in expanding the therapeutic use of PREVYMIS to a broader patient population. The ability to prevent cytomegalovirus disease in high-risk kidney transplant recipients can significantly improve patient outcomes, reducing the risk of cytomegalovirus-related complications, which are a major concern in transplant medicine. CMV is a pervasive virus that poses a substantial threat to immunocompromised individuals, particularly those undergoing organ transplants. The virus can lead to severe complications, including organ rejection and increased mortality.
Merck’s dedication to using leading-edge science to save and improve lives is evident in this latest achievement. With a legacy spanning more than 130 years, Merck has consistently brought hope to humanity through the development of critical medicines and vaccines. The company aspires to be the premier research-intensive biopharmaceutical entity globally, striving to be at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Merck fosters a diverse and inclusive global workforce and operates responsibly every day to ensure a safe, sustainable, and healthy future for all people and communities.
The promising results from the Phase III trial of PREVYMIS underscore Merck’s dedication to addressing significant public health challenges through innovative scientific approaches. By providing a new preventative treatment for cytomegalovirus, Merck aims to alleviate the substantial healthcare burden posed by this virus, improving outcomes for kidney transplant recipients and their families globally. The company looks forward to further collaboration with regulatory authorities worldwide to bring this important therapeutic option to market, reinforcing its commitment to enhancing patient care and advancing global health.
Resource: Pharmaceutical Business Review, July 22, 2024
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