Full Press Release Details
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,
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
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
(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
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.
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
Sandrine Guendoul | + 33 6 25 09 14 25
Evan Berland | +1 215 432 0234 | evan.berland@sanofi.com
Nicolas Obrist | + 33 6 77 21 27 55 | nicolas.obrist@sanofi.com
Victor Rouault | + 33 6 70 93 71 40
Timothy Gilbert | + 1 516 521 2929 |
Thomas Kudsk Larsen |+ 44 7545 513 693 | thomas.larsen@sanofi.com
Aliz Kaisserian | + 33 6 47 04 12 11 | alize.kaisserian@sanofi.com
Arnaud Del pine | + 33 6 73 69 36 93 |
Felix Lauscher | + 1 908 612 7239 |
Keita Browne | + 1 781 249 1766 |
Nathalie Pham | + 33 7 85 93 30 17 |
Tarik Elgoutni | + 1 617 710 3587 | tarik.elgoutni@sanofi.com
Thibaud Ch telet | + 33 6 80 80 89 90 | thibaud.chatelet@sanofi.com
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