- BEYFORTUS® (nirsevimab) is the first long-acting
antibody approved in Canada for
the prevention of Respiratory Syncytial Virus (RSV) lower
respiratory tract disease in neonates and infants through their
first RSV season.i
- BEYFORTUS® is also approved for children up to
24 months of age who remain vulnerable to severe RSV disease
through their second RSV season.ii
- According to INESSS, increasing demand on emergency
services shows the need for all infant protection from
RSV.iii
TORONTO, April 18,
2024 /CNW/ - Quebec's National Institute of Excellence in
Health and Social Services (INESSS)
recommends BEYFORTUS® to be used for the
prevention of RSV lower respiratory tract disease (LRTD) in all
neonates and infants aged 8 months and younger. Furthermore,
the INESSS Standing Committee on Deliberation – Reimbursement and
Access unanimously agree that BEYFORTUS® provides
significant clinical benefits compared to placebo in reducing lower
respiratory tract infections that require medical assistance as
well as hospitalization due to RSV infection, in the healthy,
full-term, or premature pediatric population during the first RSV
season. The Committee also recognizes the therapeutic value of
BEYFORTUS® in the population for whom the risk of
developing a serious infection persists for a second RSV
season.iv
Delphine
Lansac
General Manager, Vaccines Canada,
Sanofi
"Parents and physicians who experience the impacts of RSV
annually have been waiting for a preventative option that can cover
the entire infant population and protect our most vulnerable. I
believe every baby deserves to be protected against RSV and this
recommendation for BEYFORTUS® marks
an important milestone towards achieving that goal in Quebec. Now is the time to protect all infants
against this devastating illness."
Health Canada issued a Notice
of Compliance for BEYFORTUS® in April 2023. Additionally, it was approved by the
FDA in the United States in
July 2023, the European Union in
October 2022 and in Great Britain in November 2022. Regulatory applications are also
currently under review in several other countries.
Sanofi is working with Quebec
provincial authorities to make BEYFORTUS® available to a
broad cohort of infants for the 2024-25 RSV season.
About RSV
RSV, a highly contagious virus, can lead to respiratory illness
in babies, including lung infections such as bronchiolitis and
pneumonia.v Approximately 2 out of 3 infants are
infected by RSV by their first birthday and almost all infants are
infected by the age of 2.vi Infants under 1 year
are on average almost 16 times more likely to be hospitalized for
RSV than for influenza.vii The majority of RSV
hospitalizations occur in infants without risk factors. A recent
study showed among infants hospitalized for RSV, 80% were
previously healthy and born at term.viii According to
INESSS, the increasing demand on emergency services over the past
few years and the emergence of new viral strains like COVID-19
demonstrate the need to protect all newborns and infants from
RSV.ix Currently, only a small fraction of infants born
in Canada have access to RSV
protection.
About BEYFORTUS®
BEYFORTUS® is a single-dose, long-acting
antibody designed to help prevent RSV lower respiratory tract
disease (LRTD) for neonates and infants during
their first RSV season.
BEYFORTUS® is also indicated for children
up to 24 months of age who remain vulnerable
to severe RSV disease through their second RSV season.
BEYFORTUS® offers timely protection against RSV lower
respiratory tract disease lasting at least 5 months, to coincide
with the RSV season.
BEYFORTUS® is
administered directly to neonates and infants as a
single dose and offers rapid protection via an
antibody to help prevent LRTD caused by RSV, without requiring
activation of the immune system. BEYFORTUS®
administration can be timed to the start of the RSV season.
In March 2017, Sanofi and AstraZeneca announced an
agreement to develop and commercialize BEYFORTUS®. Under
the terms of the agreement, AstraZeneca leads development and
manufacturing activities and Sanofi leads commercialization
activities and records revenues. Under the terms of the global
agreement, Sanofi made an upfront payment of €120m, has paid
development and regulatory milestones of €120m and €25m in
sales-related milestones. Sanofi will pay up to a further
€350m upon achievement of additional regulatory and
sales-related milestones. The two companies share costs and profits
in all territories except in the U.S. where
Sanofi consolidates 100% of the economic benefits in its
Business Operating Income.
About Sanofi
Sanofi is an innovative global healthcare company, driven by one
purpose: we chase the miracles of science to improve people's
lives. Our team, across some 100 countries, is dedicated to
transforming the practice of medicine by working to turn the
impossible into the possible. We provide potentially life-changing
treatment options and life-saving vaccine protection to millions of
people globally, while putting sustainability and social
responsibility at the center of our ambitions.
In Canada, we employ over 2,000 people. We invest 20% of our
revenue annually in biopharma research (representing $1.2 billion CAD in R&D investment over the
last decade) creating jobs, business, and opportunities throughout
the country. We are also on track to deliver over $2 billion CAD in new infrastructure investments
by 2028, including two new vaccine manufacturing facilities at our
Toronto Campus.
In 2024, we are celebrating 110 years of heritage dedicated to
developing innovative health solutions for Canadians. What started
as a small laboratory in May of 1914, recognized for having
advanced some of the greatest contributions to public health, both
nationally and globally, has evolved to become the largest
biomanufacturing facility in Canada.
______________________________________________
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1 Per
INESSS, newborns and infants whose mothers received a vaccine for
RSV prevention, and who were born more than 2 weeks after the
administration of the vaccine, are not eligible to receive
nirsevimab for the current or upcoming season.
|
______________________________________________
i BEYFORTUS® Product Monograph. Sanofi
Pasteur Limited. 14 March 2024.
|
ii
BEYFORTUS® Product Monograph. Sanofi Pasteur
Limited. 14 March 2024.
|
iii Institut
national d'excellence en santé et en services sociaux:
BEYFORTUSMC: Prévention des infections graves par le
virus respiratoire syncytial chez l'enfant. Accessed 11 April 2024
Extrait d'avis au ministre sur Beyfortus (inesss.qc.ca)
|
iv Institut national d'excellence en
santé et en services sociaux: BEYFORTUSMC: Prévention
des infections graves par le virus respiratoire syncytial chez
l'enfant. Accessed 11 April 2024 Extrait d'avis au ministre sur
Beyfortus (inesss.qc.ca)
|
v Public Health Agency of Canada.
Accessed 21 February 2024. Respiratory syncytial virus (RSV):
Canadian Immunization Guide - Canada.ca
|
vi Simoes EAF. Lancet 1999;
354:847-852
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vii Demont C
et al. BMC Infect Dis 2021; 21(1) : 730, Sanchez-Luna M et al.
Curr Med Res Opin 2016; 32(4) : 693-698, Kobayashi Y et. Al. J
Infect Dis 2022; 226 :386-395, Yu J et al. Emerg Infect Dis
2019; 25(6) : 1127-1135, Thwaites R et al. Eur J Pediatr 2020;
179(5): 791-799, Arriola C et al. J Pediatric Infect Dis Soc 2020;
8(12): 2048.
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viii Pisesky
et al. PloS one 11.3 (2016): e0150416
|
ix Institut
national d'excellence en santé et en services sociaux:
BEYFORTUSMC: Prévention des infections graves par le
virus respiratoire syncytial chez l'enfant. Accessed 11 April 2024
Extrait d'avis au ministre sur Beyfortus (inesss.qc.ca)
|
SOURCE Sanofi-Aventis Canada Inc.