Press Release: European Commission grants first approval worldwide
of Beyfortus® (nirsevimab) for prevention of RSV disease in infants
European Commission grants first approval worldwide of
Beyfortus® (nirsevimab) for prevention of RSV disease in
infants
- Beyfortus is the first and only
broadly protective option against RSV for newborns and infants
- Results from the clinical development
program reinforce Beyfortus’ consistency in reducing RSV infections
requiring medical care, including hospitalizations
Paris,
November 4,
2022. The European Commission has approved Beyfortus®
(nirsevimab) for the prevention of respiratory syncytial virus
(RSV) lower respiratory tract disease in newborns and infants
during their first RSV season. RSV is a common and highly
contagious seasonal virus, infecting nearly all children by the age
of two.1,2 Beyfortus is the first and only single-dose RSV
protective option for the broad infant population, including those
born healthy, at term or preterm, or with specific health
conditions. Beyfortus is being developed jointly by Sanofi and
AstraZeneca.
Thomas TriompheExecutive Vice
President, Vaccines, Sanofi“Today is a landmark day for RSV
prevention, as decades of research and development come together in
the world’s first approval of a broadly protective option against
RSV disease. Once launched, Beyfortus will offer parents the
ability to help protect their babies during their first RSV
season.”
Iskra
ReicVaccines and Immune Therapies Unit,
AstraZeneca “Beyfortus is the first single-dose passive
immunization against respiratory syncytial virus to gain approval
in Europe and is also the first and only preventative option
approved for a broad infant population. Today’s marketing
authorization of Beyfortus marks a significant achievement for the
scientific community and addresses a persistent, global unmet need
in RSV prevention.”
Silke MaderChairwoman of the
Executive Board and Co-Founder of the European Foundation for the
Care of Newborn Infants (EFCNI) “Respiratory syncytial virus
represents a health threat among infants, and each year we see the
impact it can have on families, healthcare providers and the
healthcare system. At EFCNI, we are excited about the opportunity
to expand prevention efforts to all infants, as we believe this can
help ease the current emotional, physical and financial burdens of
RSV.”
The European Commission is the first regulatory
body to grant approval to Beyfortus. The approval was based on
results from the Beyfortus clinical development program, including
the Phase 3 MELODY, Phase 2/3 MEDLEY and Phase 2b trials and
follows the recommendation by The Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency in September
2022.3-11 In the MELODY and Phase 2b trials, Beyfortus met its
primary endpoint of reducing the incidence of medically attended
lower respiratory tract infections (LRTI) caused by RSV during the
RSV season vs. placebo with a single dose.3-8 The safety profile of
Beyfortus was similar to placebo. Beyfortus also demonstrated a
comparable safety and tolerability profile to palivizumab in the
Phase 2/3 MEDLEY trial.9-10,12
RSV is the most common cause of LRTI, including
bronchiolitis and pneumonia, in infants.13 It is also a
leading cause of hospitalization in all infants, with most
hospitalizations for RSV occurring in healthy infants born at
term.14-17 Globally, in 2019, there were approximately 33 million
cases of acute lower respiratory infections leading to more than
three million hospitalizations, and it was estimated that there
were 26,300 in-hospital deaths of children younger than five
years.18 RSV-related direct medical costs, globally —including
hospital, outpatient and follow-up care — were estimated at €4.82
billion in 2017.19
About
Beyfortus
Beyfortus®, a long-acting antibody designed for
all infants for protection against RSV disease from birth through
their first RSV season with a single dose, is developed jointly by
Sanofi and AstraZeneca.
Beyfortus has been developed to offer newborns
and infants direct RSV protection via an antibody to help prevent
LRTI caused by RSV. Monoclonal antibodies do not require the
activation of the immune system to help offer timely, rapid and
direct protection against the disease.20
Beyfortus has been granted marketing
authorization in the European Union for the prevention of RSV lower
respiratory tract disease in newborns and infants from birth during
their first RSV season.
In March 2017, Sanofi and AstraZeneca announced
an agreement to develop and commercialize Beyfortus.
Under the terms of the agreement, AstraZeneca leads all development
and manufacturing activities and Sanofi leads commercialization
activities and records revenue. 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.
Beyfortus has been granted 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 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
(AMED). The safety and efficacy of Beyfortus was evaluated under an
accelerated assessment procedure by the EMA.
About the clinical trials
The Phase 2b trial was a randomized,
placebo-controlled trial designed to measure the efficacy of
Beyfortus®(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 Beyfortus or placebo. The primary endpoint was met,
reducing the incidence of medically attended LRTI, caused by RSV by
70.1% (95% CI: 52.3, 81.2) compared to placebo. Between November
2016 and December 2017, 1,453 infants were randomized (Beyfortus,
n=969; placebo, n=484) at the RSV season start. Studies were
conducted in both hemispheres, at 164 sites in 23
countries.5,6 Data was published in the New England
Journal of Medicine (NEJM) in July 2020. The dosing
regimen was recommended based on further exploration of the phase
2b data.5 The subsequent Phase 3 study, MELODY, applied the
recommended dosing regimen.3,4
The Phase 3 MELODY trial was a randomized,
placebo-controlled trial conducted across 21 countries designed to
determine efficacy of Beyfortus 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.3,4 The primary endpoint was
met, reducing the incidence of medically attended LRTI, such as
bronchiolitis or pneumonia, caused by RSV by 74.5% (95% CI 49.6,
87.1; P<0.001) compared to placebo. Infants were randomized
(2:1) to receive a single 50mg (in infants weighing <5kg) or
100mg (in infants weighing ≥5kg) intramuscular injection of
Beyfortus or placebo. Between July 2019 and March 2020, 1,490
infants were randomized to either Beyfortus or placebo at the RSV
season start.3,4 Data was published on the primary
analysis in NEJM in March 2022.
Findings from Beyfortus’ clinical trial program
include a pre-specified pooled analysis of the Phase 3 MELODY trial
and the recommended dose from the Phase 2b trial, in which an
efficacy (relative risk reduction versus placebo) of 79.5% (95% CI
65.9, 87.7; P<0.0001) was seen against medically attended LRTI,
such as bronchiolitis or pneumonia, caused by RSV in infants born
at term or preterm entering their first RSV season.7 The pooled
analysis studied healthy preterm and term infants who received the
recommended dose of Beyfortus based on weight compared to placebo
through Day 151 and showed an efficacy of 77.3% (95% CI 50.3, 89.7;
P<0.001) against RSV LRTI hospitalizations, as published
in NEJM in March 2022.3,7
MEDLEY 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 and infants with congenital heart disease (CHD)
and/or chronic lung disease of prematurity (CLD) eligible to
receive palivizumab.9,10 Between July 2019 and May 2021,
approximately 918 infants entering their first RSV season were
randomized to receive a single 50mg (in infants weighing <5kg)
or 100mg (in infants weighing ≥5kg) intramuscular injection of
Beyfortus or palivizumab. Safety was assessed by monitoring the
occurrence of treatment emergent adverse events (TEAEs) and
treatment emergent serious adverse events (TESAEs) through 360 days
post-dose.9,10 Serum levels of Beyfortus following dosing (on day
151) in this trial were comparable with those observed in the Phase
3 MELODY trial, indicating similar protection in this population to
that in the healthy term and late preterm infants is likely.9 Data
was published in NEJM in March 2022.
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.3-10 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 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
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Media RelationsSandrine
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| nicolas.obrist@sanofi.comKate
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References
- Glezen WP et al. Risk of primary
infection and reinfection with respiratory syncytial virus. Am J
Dis Child. 1986;140(6):543-5463.
- Collins et al. Viral and host
factors in human respiratory syncytial virus pathogenesis. Journal
of Virology. 2008:2040–2055.
- 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.
- Clinicaltrials.gov. A Study to
Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of
Medically Attended RSV LRTI in Healthy Late Preterm and Term
Infants (MELODY). https://clinicaltrials.gov/ct2/show/NCT03979313.
Accessed October 2022.
- Clinicaltrials.gov. A Study to
Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of
Medically Attended RSV LRTI in Healthy Preterm Infants. (MEDI8897
Ph2b). https://clinicaltrials.gov/ct2/show/results/NCT02878330.
Accessed October 2022.
- 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.
- 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.
- Domachowske J, MD et al. Safety of
Nirsevimab for RSV in Infants with Heart or Lung Disease or
Prematurity. N Engl J Med. 2022; 386 (9).
- Clinicaltrials.gov. A Study to
Evaluate the Safety of MEDI8897 for the Prevention of Medically
Attended Respiratory Syncytial Virus (RSV) Lower Respiratory Track
Infection (LRTI) in High-risk Children.
https://clinicaltrials.gov/ct2/show/NCT03959488 (MEDLEY). Accessed
October 2022.
- European
Medicines Agency. Beyfortus Summary of Committee for Medicinal
Products for Human Use Opinion Available at:
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/beyfortus.
Accessed October 2022
- Synagis - Summary of Product
Characteristics (SmPC) - (eMC) [Internet]. Available from:
https://www.ema.europa.eu/en/documents/product-information/synagis-epar-product-information_en.pdf
Accessed October 2022.
- 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.
- Centers for Disease Control and
Prevention. Vaccines & Immunizations. August 18, 2017.
https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed
October 2022.
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