Press Release: New Beyfortus data featured at IDWeek reinforce real-world effectiveness against RSV disease and hospitalization in infants
09 Octobre 2024 - 7:00AM
UK Regulatory
Press Release: New Beyfortus data featured at IDWeek reinforce
real-world effectiveness against RSV disease and hospitalization in
infants
New Beyfortus data featured at IDWeek reinforce
real-world effectiveness against RSV disease and hospitalization in
infants
Paris, October 9, 2024. Sanofi
advances its ambition to protect all infants from respiratory
syncytial virus (RSV) disease with new Beyfortus (nirsevimab) data
to be presented at the Infectious Disease Society of America’s
IDWeek 2024 annual meeting in Los Angeles, California, from October
16-19, 2024.
Thomas Triomphe
Executive Vice President, Vaccines, Sanofi
“The data featured at IDWeek from several national immunization
programs will reinforce the proven efficacy and favorable safety
profile of Beyfortus against RSV disease and hospitalization in
infants. In just the first year of implementation, Beyfortus has
demonstrated high real-world effectiveness consistently exceeding
80%. In addition, Beyfortus delivers this protection in the right
dose for the right baby. We're proud to set a new standard with
Beyfortus as the only approved and proven RSV protection for
infants regardless of whether they are born before or during the
RSV season, at term or preterm, healthy or with underlying
conditions.”
Beyfortus doses continue to be shipped to
meet global commitments ahead of the 2024-2025 RSV season. A second
manufacturing filling line has been approved by regulatory
authorities in the US, Canada, and Europe and represents the
majority of our supply for the 2024-2025 season. A third filling
line, expected to provide additional doses for the 2024-2025
season, is approved by the European Medicines Agency and under
review by the US Food and Drug Administration.
Beyfortus and RSV data at IDWeek
2024
- Thursday, October 17,
12:15-1:30 pm PT: RSV Prophylaxis with Nirsevimab in
Infants: Systematic Review of Early Real-World Evidence on
Effectiveness and Impact (Sanofi, presented by Oliver Martyn, MPH,
Poster# P-631)
- Thursday, October 17,
12:15-1:30 pm PT: Implementation and Uptake of Nirsevimab
within Nemours Children’s Health Delaware Healthcare System
(independent study by Nemours Children's Health Delaware, presented
by Sara Mann, Poster# P-633)
- Thursday, October 17,
1:15-2:00 pm PT Preventing RSV Lower Respiratory Tract
Disease in Infants: The First Year in Review (Sanofi, Learning
Lounge event)
- Thursday, October 17,
1:45-3:00 pm PT: Universal Immunization Strategy Against
Respiratory Syncytial Virus (RSV) Prevention in Chile with
Nirsevimab during the 2024 Winter Season: First Southern Hemisphere
Nationwide Effectiveness Data (independent study by University of
Chile, presented by Juan Pablo Torres-Torretti, MD, PhD, during the
Late Breaker Abstract Session: Respiratory Viruses Across All Ages,
#169).
- Friday, October 18,
12:15-1:30 pm PT: Significant Reduction in Disease Burden
and a Shift in Clinical Diagnoses in Children Hospitalized with
Respiratory Syncytial Virus (RSV) after Nirsevimab Implementation
in Catalonia (Spain) (independent study presented by Anna
Creus-Costa, MD, Poster# P-1186)
- Friday, October 18,
12:15-1:30 pm PT: The burden of respiratory syncytial
virus among Brazilian infants (BONSAI study): preliminary results
(Sanofi, presented by Manoel Ribeiro, MD, PhD, Poster# P-1199)
- Saturday, October 19,
12:15-1:30 pm PT: Nirsevimab in Patient Samples Does Not
Interfere with Respiratory Syncytial Virus (RSV) Detection by
Commercially Available Rapid Antigen Tests (AstraZeneca, presented
by Sarah R. Sincero, BSc, Poster# P-2179)
About RSV
RSV is a highly contagious virus that can lead to serious
respiratory illness for infants.1 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.1,2 RSV is the most common cause of lower
respiratory tract disease, including bronchiolitis and pneumonia,
in infants.3 It is also a leading cause of
hospitalization in infants worldwide, with most hospitalizations
for RSV occurring in healthy infants born at term.4-7
Globally, in 2019, there were approximately 33 million cases of
acute lower respiratory infections leading to more than 3 million
hospitalizations in children younger than 5 years.8
RSV-related direct medical costs, globally — including hospital,
outpatient and follow-up care — were estimated at €4.82 billion in
2017.9
About Beyfortus
Beyfortus (nirsevimab) is the first immunization designed for all
infants for protection against RSV disease through their first RSV
season, including for those born healthy at term or preterm, or
with specific health conditions. Beyfortus is also designed to
protect children up to 24 months of age 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 rapid
protection to help prevent lower respiratory tract disease caused
by RSV without requiring activation of the immune system. Beyfortus
administration can be timed to coincide with the RSV season.
Beyfortus has been approved for use in the European
Union, the US, 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 Priority Review designation by
The China Center for Drug Evaluation under the National Medical
Products Administration; Breakthrough Therapy Designation and Fast
Track Designation from the US Food and Drug 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.
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
Media Relations
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References:
- U.S. Centers for Disease Control
and Prevention. RSV in Infants and Young Children.
https://www.cdc.gov/rsv/high-risk/infants-young-children.html.
Accessed August 2023.
- Walsh EE. Respiratory Syncytial
Virus Infection: An Illness for All Ages. Clinics in Chest
Medicine. 2017;38(1):29-36.
https://doi.org/10.1016/j.ccm.2016.11.010.
- R K. Respiratory Syncytial Virus
Vaccines. Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds
Plotkin’s Vaccines 7th ed Philadelphia. 2018;7th ed.
Philadelphia:943-9.
- Leader S, Kohlhase K. Respiratory
syncytial virus-coded pediatric hospitalizations, 1997 to 1999.
The Pediatric infectious disease journal.
2002;21(7):629-32.
- McLaurin KK, Farr AM, Wade SW,
Diakun DR, Stewart DL. Respiratory syncytial virus hospitalization
outcomes and costs of full-term and preterm infants. Journal of
Perinatology: official journal of the California Perinatal
Association. 2016;36(11):990-6.
- Rha B, et al. Respiratory Syncytial
Virus-Associated Hospitalizations Among Young Children: 2015-2016.
Pediatrics. 2020;146:e20193611.
- Arriola CS, 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;9:587-595.
- Li Y, et al. Global, regional, and
national disease burden estimates of acute lower respiratory
infections due to respiratory syncytial virus in children younger
than 5 years in 2019: a systematic analysis. Lancet.
2022;399:92047–64.
- Zhang S, et al. Cost of Respiratory
Syncytial Virus-Associated Acute Lower Respiratory Infection
Management in Young Children at the Regional and Global Level: A
Systematic Review and Meta-Analysis. J Infect Dis.
2020;222(Suppl 7):S680-687.
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