Nirsevimab
demonstrated
protection against
respiratory syncytial virus disease
in healthy infants in Phase 3
trial
- Respiratory Syncytial Virus (RSV)
is the leading cause of hospitalization in all infants.1-5
- Nirsevimab is being investigated as
a first-in-class single dose immunization to provide protection for
all infants entering their first RSV season.
- Nirsevimab met its Phase 3 primary
endpoint earlier than anticipated; regulatory submissions for
all-infant indication to begin in 2022.
PARIS – April 26,
2021 – Positive topline results from the Phase 3 MELODY
trial showed nirsevimab reduced lower respiratory tract infections
(LRTI) requiring medical attention (inpatient or outpatient) due to
respiratory syncytial virus (RSV) in healthy preterm and term
infants. RSV is the most common cause of LRTI and the leading cause
of hospitalizations in all infants.1-5
Nirsevimab reached its primary endpoint,
achieving a statistically significant absolute reduction of LRTI
caused by RSV in healthy preterm and term infants compared to
placebo through a typical RSV season. No clinically meaningful
differences in safety results between the nirsevimab and placebo
groups were seen. The overall safety profile of nirsevimab in the
trial remains consistent with previously reported results.
Results will be presented at an upcoming
scientific congress and are anticipated to form the basis of
regulatory submissions.
“Despite respiratory syncytial virus being the
leading cause of pneumonia and bronchiolitis in the first year of
life, there is no routine preventative option currently approved
for all infants,” said Dr William Muller, Associate Professor,
Pediatrics, Northwestern University Feinberg School of
Medicine and Scientific Director, Clinical and Community
Trials, Ann & Robert H. Lurie Children’s Hospital of
Chicago, Illinois, US and primary investigator of the MELODY Phase
III trial. “These exciting trial data demonstrate the potential for
nirsevimab to change the prevention landscape not only by providing
protection to a broad population of infants across the full
respiratory syncytial virus season, but also by achieving this with
a single dose.”
Nirsevimab, being developed in partnership with
AstraZeneca, is the first investigational extended half-life
monoclonal antibody (mAb) aiming to protect all infants
entering their first RSV season, when they are at highest risk for
severe RSV disease.1,6,7 With nirsevimab, a protective
antibody is administered directly to the infant with the goal of
providing rapid protection.
In contrast to other options for RSV under
development, such as maternal vaccines, nirsevimab was
designed to be administered at birth to infants born during the RSV
season or at the season’s start for infants born prior to the
season.
“Respiratory syncytial virus is the leading
cause of hospitalizations in all infants,” said Jean-François
Toussaint, Global Head of Research and
Development, Sanofi Pasteur. “In fact, most hospitalizations
occur in otherwise healthy infants born at term. It’s clear all
infants need protection from RSV, and we hope nirsevimab becomes an
important addition to routine immunization schedules.”
“These ground-breaking results mark a major
scientific advancement in our effort to provide protection against
respiratory syncytial virus for all infants. Nearly all children
will contract the virus before age two, leading to nearly 30
million acute lower respiratory tract infections globally each
year,” said Mene Pangalos, Executive Vice President,
BioPharmaceuticals R&D, AstraZeneca. “Nirsevimab has the
potential to provide a significant public health benefit as the
first respiratory syncytial virus immunization for the general
infant population, and these data bring us one step closer to
delivering nirsevimab to infants worldwide.”
Nirsevimab is also being evaluated in a Phase
II/III MEDLEY trial which will assess the safety and tolerability
of nirsevimab compared to Synagis (palivizumab) among preterm
infants and children with chronic lung disease (CLD) and congenital
heart disease (CHD) entering their first and second RSV seasons.
The Phase II/III trial is also expected to complete early with
first data anticipated in the coming months.
About the Phase 3
MELODY study
The Phase 3 study is a randomized,
placebo-controlled trial designed to determine the incidence
of medically attended lower respiratory tract infections
(LRTI) due to Reverse Transcriptase Polymerase Chain Reaction
(RT-PCR) confirmed RSV through 150 days post-dose versus
placebo in healthy infants entering their first RSV
season. Healthy late preterm and term infants of 35 weeks 0
days or greater gestational age were randomised (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 February 2021 approximately 1,500 infants were
dosed with either nirsevimab or placebo at the
RSV season start. Research was conducted by
AstraZeneca in 21 countries. An additional
1,500 infants will be enrolled in the Northern and Southern
Hemispheres to complete the safety evaluation.
Last July detailed results from the positive
Phase 2b trial for nirsevimab were published in the NEJM which
showed a significant reduction in medically attended lower
respiratory tract infections, mainly bronchiolitis and pneumonia,
and hospitalizations caused by respiratory syncytial virus (RSV) in
healthy preterm infants.
About RSV
RSV is a common, contagious virus that infects
the respiratory tract, causing millions of hospitalizations
globally in infants, and is the most common cause of bronchiolitis
and pneumonia in children younger than one year.1-5,8,9
Hospitalization rates due to RSV infection are consistently highest
in the first year of life – with infants under one year
representing 75% of RSV hospitalizations in children under 5
years.2,10,11 Most hospitalizations for RSV occur in otherwise
healthy infants born at term.2,11-13 Moreover, medically-attended
LRTIs are associated with increased costs to the healthcare
system.14
About
nirsevimab
Nirsevimab is an extended half-life RSV mAb
being developed as a passive immunization for the prevention of
LRTI caused by RSV. It is designed for use in a broad infant
population, including all infants experiencing their first RSV
season and infants with congenital heart disease or chronic lung
disease entering their first and second RSV season.15,16
Nirsevimab is designed to provide RSV protection
via an antibody given directly to an infant to help prevent
LRTI caused by RSV, unlike active immunization, where a person’s
immune system is activated to prevent or fight infection through a
vaccine.17 Passive immunization could offer rapid protection unlike
active immunization, which can take weeks to develop
protection.17
In March 2017, AstraZeneca and Sanofi announced
an agreement to develop and commercialize nirsevimab.
Under the terms of the agreement, AstraZeneca leads all development
activity through initial approvals and retains manufacturing
activities and Sanofi will lead commercialization
activities. Nirsevimab is currently under clinical
investigation and its safety and efficacy have not been reviewed by
any regulatory authority.Editor’s note: In January
2021, nirsevimab received the Promising Innovative Medicine (PIM)
Designation from the UK Medicines and Healthcare Products
Regulatory Agency (MHRA) and was also granted the Breakthrough
Therapy Designation (BTD) by the China Center for Drug Evaluation
(CDE) under the National Medical Products Administration. In
February 2019, the US Food and Drug Administration
granted Breakthrough Therapy Designation for nirsevimab
for the prevention of LRTI caused by RSV, and the European
Medicines Agency (EMA) granted access to its PRIority
MEdicines (PRIME) scheme for the same
indication. In Japan, nirsevimab was also selected by
the Japan Agency for Medical Research and Development (AMED) as “a
medicine for prioritized development” under the Project for Drug
Selection to Promote New Drug Development in Pediatrics.
About Sanofi Sanofi is dedicated to
supporting people through their health challenges. We are a global
biopharmaceutical company focused on human health. We prevent
illness with vaccines, provide innovative treatments to fight pain
and ease suffering. We stand by the few who suffer from rare
diseases and the millions with long-term chronic
conditions. With more than 100,000 people in 100 countries,
Sanofi is transforming scientific innovation into healthcare
solutions around the globe. Sanofi, Empowering Life |
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KressmannTel.: +1 (732) 532
53-18Nicolas.Kressmann@sanofi.com |
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Respiratory Syncytial Virus–Associated Hospitalizations Among Young
Children: 2015–2016. Pediatrics. 2020;146(1):e20193611.3. Leader
S., et al. Recent trends in severe respiratory syncytial virus
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2012;12(2):92-975. Reeves RM et al. Estimating the burden of
respiratory syncytial virus (RSV) on respiratory hospital
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2007-2012. Influenza Other Respir Viruses. 2017;11(2):122-1296.
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al. Estimated Burden of Community-Onset Respiratory Syncytial
Virus–Associated Hospitalizations Among Children Aged <2 Years
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2014 American Academy of Pediatrics Immunoprophylaxis Policy on the
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Hospitalizations among Preterm Infants. Am J Perinatol. 2020
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Acquired on Intensive Care Units: a Retrospectively Matched Cohort
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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 April
2021.16. 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. Accessed April
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https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed
April 2021
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