- VRAYLAR, an atypical antipsychotic medication, received its
Notice of Compliance from Health Canada on April 22, 2022.
- Following the positive recommendation from INESSS issued in
October 2022, VRAYLAR completed
negotiations at pCPA and has an active letter of intent (LOI).
Québec and the federal plans (NIHB, CSC and VAC) have subsequently
listed VRAYLAR, for the treatment of schizophrenia, as a result of
this completed negotiation and LOI.
MONTREAL, Sept. 4,
2024 /CNW/ - AbbVie (NYSE: ABBV) today announced that
Canada's Drug Agency (CDA,
formerly CADTH) has recommended that VRAYLAR be reimbursed
with conditions, for the treatment of schizophrenia in adults.
This recommendation supersedes the CADTH recommendation for this
drug and indication dated August 26,
2022.
"We applaud CDA for this positive reimbursement recommendation,
along with the acknowledgement of the important unmet need for
better management of negative symptoms of schizophrenia," says
Chris Summerville, CEO of the
Schizophrenia Society of Canada.
"We are hopeful that this step towards equitable access to VRAYLAR
will help meet this need for many Canadians."
Schizophrenia is a severe mental illness that can impact a
person's ability to function, and often presents symptoms that can
change over time. Symptoms can include hallucinations, disorganized
speech, social withdrawal, and catatonic behaviour. An estimated
300,000 Canadians are impacted by schizophrenia.1 Only
15% of schizophrenia patients in Canada are employed2, which means
that they likely do not have access to private insurance and rely
on public drug plans to access the medications they require to
manage their symptoms.
"Psychiatric disorders are complex and challenging to treat
because every individual I see has unique needs. In order for me to
personalize treatment, due to the differences in treatment response
and tolerability, I need access to many options," says
psychiatrist, Dr. Diane McIntosh.
"I'm really happy with CDA's recommendation regarding cariprazine
because it's a unique compound that has become an important tool I
can offer to my patients, as we build their path to recovery. This
is great news for Canadians living with this severe mental
illness."
"This important milestone for VRAYLAR speaks to AbbVie's
commitment to not only bring new therapeutic options for severe
mental illness to Canada, but to
work with governments, clinicians and community stakeholders to
reduce disparities and make these medicines accessible to all
Canadian patients," says Rami Fayed, Vice President and General
Manager, AbbVie Canada.
About VRAYLAR® (cariprazine)3
VRAYLAR is an oral, once daily atypical antipsychotic, is
indicated:
- for the treatment of schizophrenia in adults.
- as monotherapy for:
- bipolar mania: acute management of manic or mixed episodes
associated with bipolar I disorder in adults, and
- bipolar depression: acute management of depressive episodes
associated with bipolar I disorder in adults.
The mechanism of action of cariprazine in schizophrenia and
bipolar I disorder is unknown. However, the therapeutic effect of
cariprazine may be mediated through a combination of partial
agonist activity at central dopamine D3, D2 and serotonin 5-HT1A
receptors and antagonist activity at 5-HT2A receptors. Cariprazine
forms two major metabolites, desmethyl cariprazine (DCAR) and
didesmethyl cariprazine (DDCAR), that have in vitro receptor
binding and functional activity profiles similar to the parent
drug.
VRAYLAR is contraindicated in patients who are hypersensitive to
cariprazine or to any ingredient in the formulation, including any
non-medicinal ingredient, or component of the container. VRAYLAR is
also contraindicated with concomitant use with strong and moderate
CYP3A4 inhibitors / inducers. Due to the slow elimination of
cariprazine and its metabolites, treatment with strong and moderate
CYP3A4 inhibitors must be initiated at least 2 weeks after VRAYLAR
discontinuation.
VRAYLAR is being developed jointly by AbbVie and Gedeon Richter
Plc, with AbbVie responsible for commercialization in the U.S.,
Canada, Japan, Taiwan
and certain Latin American countries (including Argentina, Bolivia, Brazil, Chile, Colombia, Ecuador, Mexico, Peru
and Venezuela).
Please consult the VRAYLAR Product Monograph for important
safety information on serious warnings and precautions, other
warnings and precautions, adverse reactions, interactions, dosing
and conditions of use. The Product Monograph is also available by
calling 1-888-704-8271.
About AbbVie
AbbVie's mission is to discover and deliver innovative medicines
that solve serious health issues today and address the medical
challenges of tomorrow. We strive to have a remarkable impact on
people's lives across several key therapeutic areas: immunology,
oncology, neuroscience, eye care, virology, women's health and
gastroenterology, in addition to products and services across its
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.ca. Follow AbbVie Canada on Twitter,
on Instagram or find us on LinkedIn.
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1
Schizophrenia Society of Canada. Learn more about Schizophrenia.
https://schizophrenia.ca/about-schizophrenia/ . Accessed August
2024.
|
2 Canada's
Public Policy Forum (2014). Schizophrenia in Canada: The Social and
Economic Case for a Collaborative Model of Care. 2014.:
https://ppforum.ca/wp-content/uploads/2018/03/Schizophrenia-in-Canada-Final-report.pdf
Accessed August 2024.
|
3 VRAYLAR Product Monograph. AbbVie
Corporation.
https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VRAYLAR_PM_EN.pdf
Accessed August 2024.
|
SOURCE AbbVie Canada