Press Release: New Beyfortus data featured at IDWeek reinforce real-world effectiveness against RSV disease and hospitalization in infants
October 09 2024 - 12:00AM
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 TriompheExecutive 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 RSVRSV 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 BeyfortusBeyfortus (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 SanofiWe 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 RelationsSandrine
Guendoul | + 33 6 25 09 14 25
| sandrine.guendoul@sanofi.comEvan Berland |
+1 215 432 0234 | evan.berland@sanofi.comNicolas
Obrist | + 33 6 77 21 27 55 |
nicolas.obrist@sanofi.comVictor
Rouault | + 33 6 70 93 71 40
| victor.rouault@sanofi.comTimothy
Gilbert | + 1 516 521 2929 |
timothy.gilbert@sanofi.com
Investor RelationsThomas Kudsk
Larsen |+ 44 7545 513 693 |
thomas.larsen@sanofi.comAlizé
Kaisserian | + 33 6 47 04 12 11 |
alize.kaisserian@sanofi.comArnaud
Delépine | + 33 6 73 69 36 93 |
arnaud.delepine@sanofi.comFelix
Lauscher | + 1 908 612 7239 |
felix.lauscher@sanofi.comKeita
Browne | + 1 781 249 1766 |
keita.browne@sanofi.comNathalie Pham | +
33 7 85 93 30 17 | nathalie.pham@sanofi.comTarik
Elgoutni | + 1 617 710 3587 |
tarik.elgoutni@sanofi.comThibaud Châtelet | + 33 6
80 80 89 90 | thibaud.chatelet@sanofi.com
Sanofi forward-looking
statementsThis press release contains forward-looking
statements as defined in the Private Securities Litigation Reform
Act of 1995, as amended. Forward-looking statements are statements
that are not historical facts. These statements include projections
and estimates regarding the marketing and other potential of the
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Forward-looking statements are generally identified by the words
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forward-looking information and statements are subject to various
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generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the fact that product may not
be commercially successful, the uncertainties inherent in research
and development, including future clinical data and analysis of
existing clinical data relating to the product, including post
marketing, unexpected safety, quality or manufacturing issues,
competition in general, risks associated with intellectual property
and any related future litigation and the ultimate outcome of such
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financial condition of any one of them, as well as on our employees
and on the global economy as a whole. The risks and uncertainties
also include the uncertainties discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under “Risk Factors” and “Cautionary Statement
Regarding Forward-Looking Statements” in Sanofi’s annual report on
Form 20-F for the year ended December 31, 2023. Other than as
required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or
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are the property of the Sanofi group.
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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