The conditions for the positive recommendation is supported by the findings of the Phase 3 SOLSTICE Study.1,2
TORONTO, ON – December 1, 2022 – Takeda Canada Inc. (“Takeda”) is pleased to announce that the Canada’s Drug and Health Technology Agency (CADTH) Canadian Drug Expert Committee (CDEC) recommends LIVTENCITY™ (maribavir) for public reimbursement. The recommendation is for the treatment of post-transplant cytomegalovirus (CMV) in adults.1
“Treating CMV in post-transplant patients is challenging, especially when physicians are having to balance between immunosuppressants that protect the transplant and managing the efficacy and safety of anti-viral therapy that can put the donated organ at risk,” said Dr. Carlos Cervera, Medical Lead, Transplant Infectious Diseases, University of Alberta. “Studies have shown that LIVTENCITY is less toxic than existing antiviral treatments, which is a significant step forward for patients with CMV.”
“I suffered severe pain and required hospitalization when I was diagnosed with CMV following my transplant,” said Derek Clark a double lung organ transplant recipient. “It was devastating to hear all the potential implications associated with this infection, particularly after you’ve already been through so much to receive a transplant. I believe it’s important that patients have information about CMV and access to treatment following a transplant to help them live a healthy, normal life.”
Following Health Canada’s priority review, which concluded in September 2022, LIVTENCITY was authorized for the treatment of adults with post-transplant CMV infection/disease who are refractory (with or without genotypic resistance) to one or more prior antiviral therapies.1 Health Canada’s approval was based on findings from the SOLSTICE Study, which assessed the efficacy and safety of LIVTENCITY treatment compared to Investigator Assigned Treatment (IAT) in 350 Hematopoietic Stem Cell Transplant (HSCT) and Solid Organ Transplant (SOT) recipients with CMV infections that were refractory to treatment with ganciclovir, valganciclovir, foscarnet, or cidofovir, including CMV infections with or without confirmed resistance to one or more anti-CMV agents.1
Existing antiviral treatment options for post-transplant CMV have treatment limiting adverse toxicities, such as neutropenia and nephrotoxicity, which can negatively impact patient care and the outcomes of a transplant.3 Compared to conventionally used antivirals to treat post-transplant CMV, LIVTENCITY offers twice the efficacy1 and more than 10 times less toxicity.1* The SOLSTICE Study results demonstrated consistent beneficial treatment effects regardless of transplant type, baseline CMV DNA viral load, genotypic resistance, CMV syndrome at baseline and age.1
“Takeda is committed to working with our partners to bring this essential treatment to post-transplant patients in Canada as quickly as possible,” said Rute Fernandes, General Manager, Takeda Canada. “We’re delighted with CADTH’s positive recommendation for LIVTENCITY, which underscores the necessity for an approved CMV treatment for post-transplant patients and look forward to engaging with the pan Canadian Pharmaceutical Alliance (pCPA) and provinces on the next steps.”
LIVTENCITY is a selective orally bioavailable benzimidazole riboside antiviral drug with a novel mechanism of action against human CMV (HCMV).1 LIVTENCITY attaches to the UL97 encoded kinase at the adenosine triphosphate (ATP) binding site, as a consequence abolishing phosphotransferase needed in processes such as DNA replication, encapsidation, and nuclear egress of viral capsids.1
CMV is a beta herpesvirus that commonly infects humans; serologic evidence of prior infection can be found in 40%-100% of various adult populations.4 CMV typically resides latent and asymptomatic in the body but may reactivate during periods of immunosuppression. Serious disease may occur in individuals with compromised immune systems, which includes patients who receive immunosuppressants associated with various types of transplants including hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT).5,6 Out of the estimated 200,000 adult transplants per year globally, CMV is one of the most common viral infections experienced by transplant recipients, with an estimated incidence rate between 16%-56% in SOT recipients and 30%-70% in HSCT recipients. 5,7,8,9
In transplant recipients, reactivation of CMV can lead to serious consequences including loss of the transplanted organ and, in extreme cases, can be fatal.4,10 Existing therapies to treat post-transplant CMV infections may demonstrate serious side effects that require dose adjustments or may fail to adequately suppress viral replication. 6,11,12,13,14 Additionally, existing therapies may require or prolong hospitalization due to intravenous administration, side effect management and monitoring for adequate hydration.4
Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK), a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people’s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: takeda.com/en-ca
LIVTENCITY™ and the LIVTENCITY Logo™ are trademarks of Takeda Pharmaceuticals International AG
TAKEDA® and the TAKEDA Logo® are registered trademarks of Takeda Pharmaceutical Company Limited, used under license.
1 LIVTENCITY™ Product Monograph. September 23, 2022.
2 Avery, R. K., Alain, S., Alexander, B. D., Blumberg, E. A., Chemaly, R. F., Cordonnier, C., Duarte, R. F., Florescu, D. F., Kamar, N., Kumar, D., Maertens, J., Marty, F. M., Papanicolaou, G. A., Silveira, F. P., Witzke, O., Wu, J., Sundberg, A. K., & Fournier, M. (2021). Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: Results from a phase 3 randomized clinical trial. Clinical Infectious Diseases, 75(4), 690–701. https://doi.org/10.1093/cid/ciab988
3 Maffini E, et al. Expert Rev Hematol. 2016;9:585-96; Stevens DR, et al. Transpl Infect Dis. 2015;17:163–73
4 de la Hoz R. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 2002;25:S1-S12.
5 Azevedo L, Pierrotti L, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics. 2015;70(7):515-523. doi:10.6061/clinics/2015(07)09.
6 Razonable RR, Eid AJ. A Viral infections in transplant recipients. Minerva Med. 2009;100(6):23.
7 Shannon-Lowe & Emery. The effects of maribavir on the autophosphorylation of ganciclovir resistant mutants of the cytomegalovirus UL97 protein. Herpesviridae 2010, 1:4.
8 Styczynski J. Who Is the Patient at Risk of CMV Recurrence: A Review of the Current Scientific Evidence with a Focus on Hematopoietic Cell Transplantation. Infect Ther. 2018;7:1-16.
9 World Health Organization. Haematopoietic Stem Cell Transplantation HSCtx. Accessed December 2, 2020. https://www.who.int/transplantation/hsctx/en/.
10 Kenyon M, Babic A, eds. The European Blood and Marrow Transplantation Textbook for Nurses. Springer International Publishing; 2018. doi:10.1007/978-3-319-50026-3.
11 El Chaer et al. How I treat resistant cytomegalovirus infection in hematopoietic cell transplantation recipients. Blood, 2016.
12 Chemaly RF, Chou S, Einsele H, et al. Definitions of Resistant and Refractory Cytomegalovirus Infection and Disease in Transplant Recipients for Use in Clinical Trials. Clin Infect Dis. 2019;68(8):1420-1426. doi:10.1093/cid/ciy696.
13 Ljungman et al. Guidelines for the management of cytomegalovirus infection in patients with haematological malignancies and after stem cell transplantation from the 2017 European Conference on Infections in Leukaemia (ECIL7).Lancet Vol.19, Aug 2019.
14 Razonable & Humar. Cytomegalovirus in solid organ transplant recipients— Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice. Clinical Transplantation, Feb 2019.
*Refers to acute kidney injury related to foscarnet and neutropenia related to valganciclovir/ganciclovir