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."
About LIVTENCITY
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
About CMV
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
About Takeda Canada Inc.
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
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2 de
la Hoz R. Diagnosis and treatment approaches to CMV infections
in adult patients. J Clin Virol. 2002;25:S1-S12.
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3 Azevedo L, Pierrotti L, Abdala E,
et al. Cytomegalovirus infection in transplant recipients. Clinics.
2015;70(7):515-523.
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4 Razonable RR, Eid AJ. A Viral
infections in transplant recipients. Minerva Med.
2009;100(6):23.
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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.
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7 World
Health Organization. Haematopoietic Stem Cell Transplantation
HSCtx. Accessed December 2, 2020.
https://www.who.int/transplantation/hsctx/en/.
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8 Kenyon M, Babic A, eds. The
European Blood and Marrow Transplantation Textbook for Nurses.
Springer International Publishing; 2018.
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SOURCE Takeda Canada, Inc.