Takeda Canada Inc. concludes Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA) for LIVTENCITY® (maribavir) for the treatment of adults with a post-transplant cytomegalovirus (CMV) infection Français
The Letter of Intent is an important step for patients living with a post-transplant cytomegalovirus (CMV) infection to have public access to treatment.
TORONTO, May 16, 2024 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce that it has completed negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) for a Letter of Intent (LOI) for LIVTENCITY® (maribavir) for the treatment for adults with a post-transplant cytomegalovirus (CMV) infection/disease who are refractory (with or without genotypic resistance) to one or more prior antiviral therapies.1 With the LOI stage now complete, the provinces and territories may proceed in initiating their individual processes of listing LIVTENCITY as part of their formularies.
"One of the key priorities of the Canadian Immunocompromised Advocacy Network is striving to ensure immunocompromised patients across Canada have equitable access to therapeutic options regardless of where they reside," said Theresa Tang, Co-Chair, Canadian Immunocompromised Advocacy Network and 19 to Zero. "We're excited about this milestone and are hopeful the provinces will move quickly in their decision to reimburse this treatment option."
Timing of each listing will be dependent on the respective province or territory. LIVTENCITY is already covered by a majority of private insurance plans.
"Takeda remains dedicated to increasing accessibility to vital treatment options for all Canadians suffering with a post-transplant cytomegalovirus (CMV) infection," said Martin Cho, Head of Patient Value & Access, Takeda Canada Inc. "We are thrilled to conclude the LOI from the pCPA for LIVTENCITY and look forward to collaborating with provinces and territories with the intent of supporting the transplant community and its access to this treatment."
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
For contraindications, warnings, precautions, adverse reactions, drug-drug interactions, dosing, and conditions of clinical use, consult the LIVTENCITY product monograph at https://assets-dam.takeda.com/image/upload/legacy-dotcom/siteassets/en-ca/home/what-we-do/our-medicines/product-monographs/livtencity/LIVTENCITY-PM-Eng.pdf
CMV, a beta herpesvirus, commonly infects people around the world; serologic evidence of infection can be found in 40%-100% of various adult populations.2 Typically CMV remains dormant and asymptomatic in the body, however this virus may reactivate during periods of immunosuppression. Patients with compromised immune systems such as those who receive immunosuppressants associated with various types of transplants including hematopoietic stem cell transplant (HSCT) or solid organ transplant (SOT), are at risk of developing serious complications of CMV.3,4
Out of the estimated 200,000 transplants in adults 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.3,5,6,7 If untreated, CMV infection in transplant patients can lead to serious outcomes such as the loss of the transplanted organ and, in extreme cases, can be fatal.2,8
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: https://www.takeda.com/en-ca/
LIVTENCITY® and the LIVTENCITY Logo® are registered 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. February 5, 2024 |
2 de la Hoz R. Diagnosis and treatment approaches to CMV infections in adult patients. J Clin Virol. 2002;25:S1-S12. |
3 Azevedo L, Pierrotti L, Abdala E, et al. Cytomegalovirus infection in transplant recipients. Clinics. 2015;70(7):515-523. |
4 Razonable RR, Eid AJ. A Viral infections in transplant recipients. Minerva Med. 2009;100(6):23. |
5 Shannon-Lowe & Emery. The effects of maribavir on the autophosphorylation of ganciclovir resistant mutants of the cytomegalovirus UL97 protein. Herpesviridae 2010, 1:4. |
6 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. |
7 World Health Organization. Haematopoietic Stem Cell Transplantation HSCtx. Accessed December 2, 2020. https://www.who.int/transplantation/hsctx/en/. |
8 Kenyon M, Babic A, eds. The European Blood and Marrow Transplantation Textbook for Nurses. Springer International Publishing; 2018. |
SOURCE Takeda Canada, Inc.
Media Contacts: Amanda Jacobs, [email protected], +1 647-798-2231
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