Press Release: New nirsevimab data analyses reinforce efficacy
against RSV
New nirsevimab data analyses reinforce efficacy
against RSV
- A prespecified pooled analysis of
Phase 3 and Phase 2b data demonstrated an efficacy of 79.5% against
medically attended lower respiratory tract infections (LRTI),
including hospitalizations, caused by respiratory syncytial virus
(RSV)1
- Nirsevimab is the first
investigational immunization designed to protect all infants across
the RSV season with a single dose
- Two analyses are being presented at
the European Society for Paediatric Infectious Diseases
meeting1,2
Paris,
May 11,
2022. Results from a prespecified pooled analysis of the
pivotal Phase 3 MELODY and Phase 2b nirsevimab trials demonstrated
an efficacy (relative risk reduction versus placebo) of 79.5% (95%
CI 65.9 to 87.7; P<0.0001) against medically attended LRTI, such
as bronchiolitis or pneumonia, caused by RSV in infants born at
term or preterm entering their first RSV season.1
In a separate pooled post-hoc analysis of the
trials, blood samples taken from infants dosed with nirsevimab
exhibited RSV neutralizing antibodies that were approximately
50-fold higher than baseline at Day 151 post-dose. RSV neutralizing
antibody levels remained greater than 19-fold higher than placebo
recipients with no known RSV infection through Day 361, suggesting
protection may extend beyond Day 151.2
The safety profile across the nirsevimab and
placebo groups, as reported in previous trials, remains similar.3-6
These findings contribute to the growing body of evidence
suggesting that nirsevimab can protect all infants through their
first RSV season with a single dose.1-7
Eric
Simões, MDClinical Professor,
Pediatrics-Infectious Diseases, UC Denver School of Medicine“RSV
remains the most common cause of LRTI in infants and results in
seasonal epidemics globally each year. These new analyses
strengthen nirsevimab’s potential to protect all infants across the
RSV season with a single dose, which may lead to a paradigm shift
in RSV prevention.”
Jean-François ToussaintGlobal
Head of Research and Development Vaccines, Sanofi “These new
analyses are very consistent with and confirm the strong results
observed in all Phase 2 and Phase 3 studies that evaluated
nirsevimab in diverse pediatric populations. We take pride in the
progress made to develop a potential solution to address this long
unmet need for all infants.”
Mene PangalosExecutive Vice
President, BioPharmaceuticals R&D, AstraZeneca “Each year, RSV
causes seasonal epidemics of LRTIs in infants. These analyses add
to nirsevimab’s compelling body of evidence as the first potential
single-dose preventative immunization for all infants against RSV,
addressing a clear unmet need in the RSV preventative
landscape.”
The data are being presented at the 40th Annual
Meeting of the European Society for Paediatric Infectious Diseases
(ESPID) from May 9-13 in Athens, Greece.
Nirsevimab is being developed by Sanofi and
AstraZeneca.
About nirsevimab
Nirsevimab is an investigational long-acting
antibody designed to protect all infants from birth entering their
first RSV season with a single dose. Due to its extended half-life
technology, nirsevimab is being developed as a single dose for
protection of all infants through their first RSV season.5,6,8
Nirsevimab is an immunization designed to
provide direct RSV protection to all infants via an antibody to
help prevent LRTI caused by RSV. Monoclonal antibodies do not
require the activation of the immune system to help offer rapid and
direct protection against disease.9
In March 2017, Sanofi and AstraZeneca announced
an agreement to develop and commercialize nirsevimab. Under the
terms of the agreement, AstraZeneca leads all development and
manufacturing activities and Sanofi will lead commercialization
activities and record revenues. Under the terms of the global
agreement, Sanofi made an upfront payment of €120m, has paid a
development milestone of €30m and will pay up to a further €465m
upon achievement of certain development and sales-related
milestones. The two companies share all costs and profits. Revenue
from the agreement is reported as Collaboration Revenue in the
Company’s financial statements.
Nirsevimab has been granted regulatory
designations to facilitate expedited development by several
regulatory agencies around the world. These include Breakthrough
Therapy Designation by The China Center for Drug Evaluation under
the National Medical Products Administration; Breakthrough Therapy
Designation from the US Food and Drug Administration; access
granted to the European Medicines Agency (EMA) PRIority MEdicines
scheme; Promising Innovative Medicine designation by the UK
Medicines and Healthcare products Regulatory Agency; and 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 (AMED). The
safety and efficacy of nirsevimab is currently being evaluated
under an accelerated assessment procedure by the EMA. Nirsevimab
has not been approved by any regulatory authority.
About the pivotal
nirsevimab clinical trials
The Phase 2b trial was a randomized,
placebo-controlled trial designed to measure the efficacy of
nirsevimab against medically attended LRTI through 150 days
post-dose. Healthy preterm infants of 29–35 weeks’ gestation were
randomized (2:1) to receive a single 50mg intramuscular injection
of nirsevimab or placebo. Between November 2016 and December 2017,
1,453 infants were randomized (nirsevimab, n=969; placebo, n=484)
at the RSV season start. Research was conducted in both
hemispheres, at 164 sites in 23 countries.6 Data was published in
the New England Journal of Medicine (NEJM) in July 2020. The dosing
regimen was optimized based on further exploration of this data.
The subsquent Phase 3 study MELODY applied the optimized dosing
regimen.1,5
The Phase 3 MELODY trial was a randomized,
placebo-controlled trial conducted across 21 countries designed to
determine efficacy of nirsevimab against medically attended LRTI
due to RSV confirmed by reverse transcriptase polymerase chain
reaction testing through 150 days after dosing, versus placebo, in
healthy late preterm and term infants (35 weeks gestational age or
greater) entering their first RSV season.5 Infants were randomized
(2:1) to receive a single 50mg (in infants weighing <5kg) or
100mg (in infants weighing ≥5kg) intramuscular injection of
nirsevimab or placebo. Between July 2019 and March 2020, 1,490
infants were randomized to either nirsevimab or placebo at the RSV
season start.3 Data was published on the primary analysis in NEJM
in March 2022.
The prespecified pooled analyses of the Phase 3
and the Phase 2b trials looked at infants receiving the optimized
dosing regimen (infants <5 kg at dosing and receiving the 50 mg
dose from Phase 2b and the infants from Phase 3), and demonstrated
an efficacy of 79.5% (95% CI 65.9 to 87.7, P<0.0001) against
medically attended LRTI and 77.3% (95% CI 50.3, 89.7, P<0.001)
against RSV LRTI hospitalizations. The analysis was based on 2,350
infants of which 1,564 infants were randomized to receive
nirsevimab and 786 infants were randomized to receive placebo.1
The results of MELODY, Phase 2/3 MEDLEY and the
Phase 2b trials demonstrate that nirsevimab provides protection
against RSV in all infants entering their first RSV season with a
single dose.1-5 This all-infant population includes preterm,
healthy late preterm and term infants, as well as infants with
specific conditions.
These trials form the basis of regulatory
submissions that began in 2022.
About RSV
RSV is the most common cause of lower
respiratory tract infections (LRTI), including bronchiolitis and
pneumonia in infants.10 It is also a leading cause of
hospitalization in all infants, with most hospitalizations for RSV
occurring in healthy infants born at term.11-14 Globally, in 2015,
there were approximately 30 million cases of acute lower
respiratory infections leading to more than three million
hospitalizations, and it was estimated that there were 60,000
in-hospital deaths of children younger than five years.15,16 In
recent months, there has been a resurgence of RSV following the
easing of COVID-19 public health measures.17,18 Globally, in 2017,
RSV-related direct medical costs—including hospital, outpatient and
follow-up care—were estimated at €4.82 billion.19
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
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ambitions. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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References
- Simões, E, et al. Pooled efficacy
of nirsevimab against RSV lower respiratory tract infection in
preterm and term infants. ESPID 2022 Congress; 2022 May 9-13.
Hybrid Congress.
- Wilkins, D, et al. Nirsevimab for
the prevention of respiratory syncytial virus infection:
neutralizing antibody levels following a single dose. ESPID 2022
Congress; 2022 May 9-13. Hybrid Congress.
- Hammitt LL, MD et al. Nirsevimab
for Prevention of RSV in Healthy Late -Preterm and Term Infants. N
Engl J Med. 2022;386 (9): 837-846. doi: 10.1056/NEJMoa2110275.
- Griffin P, MD et al. (2020).
Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.
NEJM 2020; 383: 415-425. DOI: 10.1056/NEJMoa1913556.
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Accessed May 2022.
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- Oxford Vaccines Group. What is RSV?
https://vk.ovg.ox.ac.uk/vk/rsv. Accessed May 2022.
- Ujiie M, Tsuzuki S, Nakamoto T, et
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- Zhang S, et al. Cost of Respiratory
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