- Company planning for every eligible baby in the US to have
access to BEYFORTUS
- New BEYFORTUS filling line approved by the U.S. Food and Drug
Administration (FDA) to expand manufacturing capacity and help meet
demand
- 2 out of 3 babies get respiratory syncytial virus (RSV)
disease1
BRIDGEWATER, N.J., Sept. 16,
2024 /PRNewswire/ -- Sanofi is shipping BEYFORTUS
(nirsevimab-alip) 50mg and 100mg Injection doses in the US to
private healthcare providers and to the Centers for Disease Control
and Prevention for its Vaccines for Children program to help ensure
the majority of doses are available ahead of RSV season. The US
market is anticipated to have enough supply so that every eligible
baby born outside of the season will have access to immunization at
a regular checkup and those born during the season will have access
at birth. BEYFORTUS is the first and only long-acting monoclonal
antibody approved for the prevention of RSV lower respiratory tract
disease (LRTD) in newborns and infants born during or entering
their first RSV season, and for children up to 24 months of age who
remain vulnerable to severe RSV disease through their second RSV
season.
Thomas
Grenier
Head of Vaccines, North America,
Sanofi
"We're proud to offer BEYFORTUS doses to help protect every
eligible baby in the US this RSV season. This accomplishment aimed
at equitable access was made possible through close partnership
with the White House, Centers for Disease Control and Prevention,
the U.S. Food and Drug Administration, and healthcare providers to
make BEYFORTUS widely available. This upcoming season, we look
forward to BEYFORTUS offering its demonstrated real-world
protection to as many infants as possible."
In collaboration with AstraZeneca, which leads BEYFORTUS
development and manufacturing, doses have already been produced and
packaged on a new filling line for BEYFORTUS. With the recent FDA
approval of this filling line, these doses are now ready to ship,
expanding supply for the Northern Hemisphere ahead of the 2024/2025
RSV season (November – March).2 Another filling line is
expected to provide doses for the 2024/2025 season, adding
additional production capacity. Sanofi continues to work with
AstraZeneca to build inventory for this and future seasons.
Sanofi also took additional measures to ensure greater readiness
for this season by launching the BEYFORTUS Reservation Program,
which provides critical insight on private healthcare provider
demand and allows for prioritized fulfillment of requests placed
through the program. The company also continues to collaborate with
government agencies, including the White House's Office of Pandemic
Preparedness and Response Policy, to ensure readiness. Private
customers interested in ordering BEYFORTUS doses should contact
their Sanofi representative or request a representative
at BEYFORTUS.com.
About RSV
RSV is a highly contagious virus that can lead to serious
respiratory illness for infants.3 Two out of three
infants are infected with RSV during their first year of life and
almost all children are infected by their second
birthday.1,4 Most of the time RSV will cause a
mild, cold-like illness.5 However, RSV is the most
common cause of LRTD, including bronchiolitis and pneumonia, in
infants.2 RSV LRTD is the leading cause of
hospitalization in babies under one, with most hospitalizations for
RSV occurring in healthy infants born at term.5,6 Each
year in the US, an estimated 590,000 RSV cases in babies under one
require medical care, including physician office, urgent care,
emergency room visits and hospitalizations.7
About BEYFORTUS
BEYFORTUS is a single-dose long-acting antibody designed to help
prevent RSV LRTD in infants through 5 months, the length of the
typical RSV season in the US. For children undergoing cardiac
surgery with cardiopulmonary bypass, an additional dose of
BEYFORTUS is recommended as soon as the child is stable after
surgery. An additional dose of BEYFORTUS is also indicated for
children up to 24 months of age, regardless of body
weight, who remain vulnerable to severe RSV disease through
their second RSV season.
As a long-acting antibody provided directly to newborns and
infants as a single dose, BEYFORTUS offers fast-acting protection
to help prevent lower respiratory tract disease caused by RSV
without requiring activation of the immune system.8
BEYFORTUS administration can be timed to coincide with the RSV
season.
BEYFORTUS has been approved for use in the US, the European
Union, China, Japan, and many other countries around the
world. Special designations to facilitate expedited development of
BEYFORTUS were granted by several regulatory agencies, including
Breakthrough Therapy Designation and Fast Track
Designation from the U.S. Food and Drug Administration;
Breakthrough Therapy Designation and Priority Review designation by
The China Center for Drug Evaluation under the National Medical
Products Administration; access granted to the European
Medicines Agency (EMA) PRIority MEdicines (PRIME)
scheme and EMA accelerated assessment; Promising Innovative
Medicine designation by the UK Medicines and Healthcare products
Regulatory Agency; and BEYFORTUS has been named "a medicine for
prioritized development" under the Project for Drug Selection to
Promote New Drug Development in Pediatrics by the Japan Agency for
Medical Research and Development.
INDICATION
BEYFORTUS is a prescription medicine used
to help prevent a serious lung disease caused by Respiratory
Syncytial Virus (RSV) in:
- Newborns and babies under 1 year of age born during or entering
their first RSV season.
- Children up to 24 months of age who remain at risk of severe
RSV disease through their second RSV season.
IMPORTANT SAFETY INFORMATION
Your child should not
take BEYFORTUS if your child has a history of serious allergic
reactions to nirsevimab-alip or any of the ingredients in
BEYFORTUS.
Before your child receives BEYFORTUS, tell your healthcare
provider about all of your child's medical conditions, including if
your child:
- has ever had a reaction to BEYFORTUS.
- has bleeding or bruising problems. If your child has a problem
with bleeding or bruises easily, an injection could cause a
problem.
Tell your healthcare provider about all the medicines your child
takes, including prescription and over-the- counter medicines,
vitamins, and herbal supplements. Your infant should not receive a
medicine called palivizumab if they have already received BEYFORTUS
in the same RSV season.
Serious allergic reactions have happened with BEYFORTUS. Get
medical help right away if your child has any of the following
signs or symptoms of a serious allergic reaction:
- swelling of the face, mouth, or tongue
- difficulty swallowing or breathing
- unresponsiveness
- bluish color of skin, lips, or under fingernails
- muscle weakness
- severe rash, hives, or itching
The most common side effects of BEYFORTUS include rash and pain,
swelling, or hardness at the site of your child's injection. These
are not all the possible side effects of BEYFORTUS. Call your
healthcare provider if you have questions about side effects.
Please see full Prescribing Information,
including Patient Information for more
details.
MAT-US-2408133-v2.0-09/2024
About Sanofi
We are an innovative global healthcare
company, driven by one purpose: we chase the miracles of science to
improve people's lives. Our team, across the world, 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.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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|arnaud.delepine@sanofi.com
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thibaud.chatelet@sanofi.com
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contains forward-looking statements as defined in the Private
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Forward-looking statements are statements that are not historical
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References
1. Glezen WP, Taber LH, Frank AL, Kasel JA. Risk of primary
infection and reinfection with respiratory syncytial virus. Am J
Dis Child. 1986;140(6):543-546.
2. Respiratory Syncytial Virus Infection
(RSV). "RSV in Infants and Young Children," June 5, 2024.
https://www.cdc.gov/rsv/infants-young-children/index.html.
3. RSV Symptoms and Diagnosis | American Lung
Association.
https://www.lung.org/lung-health-diseases/lung-disease-lookup/rsv/symptoms-diagnosis.
4. Walsh, EE. Respiratory Syncytial Virus Infection: An
Illness for All Ages. Clinics in Chest Medicine.
2017;38(1):2936. https://doi.org/10.1016/j.ccm.2016.11.010.
5. Suh M, Movva N, Jiang X, et al. Respiratory
syncytial virus is the leading cause of United States infant hospitalizations,
2009-2019: a study of the national (nationwide) inpatient sample. J
Infect Dis. 2022;226(suppl 2):S154-S163.
6. Arriola CS, Kim L, Langley G, et al. Estimated burden of
community-onset respiratory syncytial virus–associated
hospitalizations among children aged <2 years in the United States, 2014-15. J Pediatric Infect
Dis Soc. 2020;9(5):587-595.
7. Rainisch G, Adhikari B, Meltzer MI, Langley G.
Estimating the impact of multiple immunization products on
medically-attended respiratory syncytial virus (RSV) infections in
infants. Vaccine. 2020;38(2):251-257.
8. Centers for Disease Control and Prevention. Vaccines
& Immunizations. August 18, 2017.
https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed
August 2023.
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