Press Release: FDA approves Beyfortus™ (nirsevimab-alip) to protect
infants against RSV disease
FDA approves Beyfortus™ (nirsevimab-alip) to protect infants
against RSV disease
- Beyfortus™ is the first monoclonal
antibody approved to protect all infants through their first RSV
season
- Across all
clinical endpoints, a single dose of Beyfortus delivered high,
consistent and sustained efficacy and favorable safety against RSV
disease
- Approval also
includes use for children up to 24 months of age who remain
vulnerable to severe RSV disease through their second RSV
season
Paris, July
17, 2023. The U.S. Food
and Drug Administration (FDA) has approved Sanofi and AstraZeneca’s
Beyfortus™ (nirsevimab-alip) for the prevention of respiratory
syncytial virus (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.
The companies plan to make Beyfortus available in the U.S. ahead of
the upcoming 2023-2024 RSV season.
RSV is the leading cause of hospitalization for
infants under the age of one in the U.S., averaging 16 times higher
than the annual rate for influenza.1,2 Each year, an estimated
590,000 RSV disease cases in infants under one require medical
care, including physician office, urgent care, emergency room
visits and hospitalizations.3
Thomas
TriompheExecutive Vice President, Vaccines,
Sanofi“Today’s approval marks an unprecedented moment for
protecting infant health in the U.S., following an RSV season that
took a record toll on infants, their families, and the U.S.
healthcare system. Beyfortus is the only monoclonal antibody
approved for passive immunization to provide safe and effective
protection for all infants during their first RSV season. I am
proud that, by prioritizing this potential game-changer, we are now
about to bring Beyfortus to American families.”
Iskra
ReicExecutive Vice President, Vaccines and Immune
Therapies, AstraZeneca“Beyfortus represents an opportunity for a
paradigm-shift in preventing serious respiratory disease due to RSV
across a broad infant population in the U.S. The science that
Beyfortus is built on demonstrates AstraZeneca’s continued
leadership in addressing the needs of the most vulnerable
populations and reducing the burden on healthcare systems.”
The FDA decision follows the positive
recommendation of the FDA Antimicrobial Drugs Advisory Committee
and was based on the extensive Beyfortus clinical development
program spanning three pivotal late-stage clinical trials. Across
all clinical endpoints, a single dose of Beyfortus demonstrated
high and consistent efficacy against RSV LRTD extending through
five months, a typical RSV season.
Beyfortus was well tolerated with a favorable
safety profile that was consistent across all clinical trials. The
overall rates of adverse events were comparable between Beyfortus
and placebo and the majority of adverse events were mild or
moderate in severity. The most common adverse events were rash and
injection site reactions.
The single administration of Beyfortus was
developed to correspond with the beginning of the RSV season for
babies born prior to the season or at birth for those born during
the RSV season. In clinical trials, Beyfortus helped prevent RSV
LRTD requiring medical care in all infant populations studied,
including those born healthy at term, late preterm or preterm, or
with specific health conditions that make them vulnerable to severe
RSV disease. RSV diseaserequiring medical care included physician
office, urgent care, emergency room visits and
hospitalizations.
Beyfortus, jointly developed by Sanofi and
AstraZeneca, was approved in the European Union in October 2022, in
Great Britain in November 2022, and recently received approval in
Canada in April 2023. Regulatory applications are also currently
under review in China, Japan and several other countries.
About RSVRSV
is a very contagious virus that can lead to serious respiratory
illness for infants, according to the Centers for Disease Control
and Prevention (CDC). RSV symptoms can include runny nose,
coughing, sneezing, fever, decrease in appetite, and wheezing.4 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.4,5 In the U.S., RSV is the leading cause of
hospitalization in infants under 12 months, averaging 16 times
higher than the annual rate for influenza.1,2 Approximately 75% of
infants hospitalized for RSV are born healthy and at term with no
underlying conditions.6 Each year in the U.S., an estimated 590,000
RSV disease cases in infants under one require medical care,
including physician office, urgent care, emergency room visits and
hospitalizations.3
About
BeyfortusIn the U.S., Beyfortus is a single-dose
long-acting antibody designed to help prevent RSV lower respiratory
tract disease in all infants through 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, provided directly to newborns and
infants as a single dose, offers rapid protection via an antibody
to help prevent LRTD caused by RSV, without requiring activation of
the immune system.7 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 €55m and will pay up to a
further€440m upon achievement of certain 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.
Beyfortus has been granted special designations
to facilitate expedited development by several regulatory agencies
around the world. These include Breakthrough Therapy Designation
and Priority Review designation by The China Center for Drug
Evaluation under the National Medical Products Administration;
Breakthrough Therapy Designation from the U.S. 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 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.
Beyfortus has been granted marketing
authorization in the European Union, Great Britain and Canada for
the prevention of RSV lower respiratory tract disease in newborns
and infants from birth through their first RSV season and is
currently undergoing regulatory review in China, Japan and several
other countries. In Canada, nirsevimab is also approved for
children up to 24 months of age who remain vulnerable to severe RSV
disease through their second RSV season and such indication is
under review at the EMA level.
About the
clinical trials
The Phase 2b trial (Trial 03) was a randomized,
placebo-controlled trial designed to measure the efficacy of
Beyfortus against medically attended lower respiratory tract
disease (LRTD) caused by RSV through 150 days post-dose in healthy
preterm infants of 29 to less than 35 weeks’ gestation (n=1,453).
Infants were randomized (2:1) to receive a single 50 mg
intramuscular injection of Beyfortus (n=969) or placebo (n=484)
regardless of weight at the RSV season start. The primary endpoint
was met, significantly reducing the incidence of medically attended
RSV LRTD by 70.1% (95% CI: 52.3, 81.2; P<0.001) compared to
placebo. In a prespecified secondary endpoint, Beyfortus reduced
medically attended RSV LRTD with hospitalization by 78.4% (95% CI
51.9, 90.3) versus placebo.
The Beyfortus dosing regimen was determined
based on further exploration of the Phase 2b data and was used in
subsequent trials as a single 50 mg dose for those who weigh less
than 5 kg, or a single 100 mg dose for those who weigh 5 kg or
greater. A post-hoc analysis of the Phase 2b study that applied the
recommended 50 mg dose in a subgroup of infants weighing less than
5 kg showed the efficacy of Beyfortus against medically attended
RSV LRTD and medically attended RSV LRTD with hospitalization was
86.2% (95% CI 68.0, 94.0) and 86.5%(95% CI 53.5, 96.1),
respectively.
The Phase 3 MELODY trial (Trial 04) was a
randomized, double-blind, placebo-controlled trial conducted across
21 countries designed to determine the safety and efficacy of
Beyfortus against medically attended LRTD caused by RSV in healthy
term and late preterm infants (35 weeks gestational age or greater)
entering their first RSV season, including efficacy against severe
disease such as hospitalization, through 150 days after dosing. The
primary endpoint was met, reducing the incidence of medically
attended RSV LRTD by 74.9% (95% CI 50.6, 87.3; P<0.001) compared
to placebo. The efficacy of Beyfortus against the secondary
endpoint of hospitalization was 60.2% (95% CI: -14.6, 86.2).
MEDLEY (Trial 05) was a Phase 2/3, randomized,
double-blind, palivizumab-controlled trial with the primary
objective of assessing safety and tolerability for Beyfortus in
preterm infants of less than 35 weeks’ gestational age and infants
with congenital heart disease (CHD) and/or chronic lung disease
(CLD) of prematurity eligible to receive palivizumab. Between July
2019 and May 2021, a total of 925 infants at higher risk for severe
RSV disease entering their first RSV season were randomized to
receive Beyfortus or palivizumab. Safety was assessed by monitoring
the occurrence of treatment emergent adverse events (TEAEs) and
treatment emergent severe adverse events (TESAEs) through 360 days
post-dose. Serum levels of Beyfortus following dosing (on day 151)
in this trial were comparable with those observed in the Phase 3
MELODY trial (Trial 04), indicating similar protection in this
population to that in healthy term and late preterm infants is
likely.
The safety profile of Beyfortus was similar to
palivizumab in the MEDLEY Phase 2/3 trial and consistent with the
safety profile in healthy term, late preterm and preterm infants
compared to placebo across the MELODY and Phase 2b trials. While
uncommon, the most reported adverse reactions were rash 14 days
post-dose, (the majority of which were mild to moderate) and
non-serious injection site reactions within 7 days post-dose.
The results of MELODY, Phase 2/3 MEDLEY and the
Phase 2b trials illustrate that Beyfortus helps protect infants
during their first RSV season against RSV disease with a single
dose. This all-infant population includes healthy term, late
preterm, and preterm infants, as well as infants with specific
health conditions that make them vulnerable to severe RSV
disease.
These trials form the basis of regulatory
submissions that began in 2022.
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 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.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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sandrine.guendoul@sanofi.comSally
Bain | + 1 617 834 6026 |
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