Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY
trial
Nirsevimab shows positive topline
results in RSV Phase 2/3 MEDLEY
trial
- Respiratory syncytial virus (RSV)
is the leading cause of hospitalization in all
infants1,2
- Nirsevimab is being investigated as
a first-in-class single dose immunization to provide protection for
all infants entering their first RSV season
- MEDLEY is the third pivotal trial
to report positive data for nirsevimab; regulatory submissions
planned for the first half of 2022
PARIS – June 28, 2021 - In
positive topline results from the Phase 2/3 MEDLEY trial,
nirsevimab showed a similar safety and tolerability profile
compared to palivizumab when administered to preterm infants or
those with chronic lung disease (CLD) or congenital heart disease
(CHD) entering their first respiratory syncytial virus (RSV)
season.3 Safety and tolerability were assessed by the occurrence of
all treatment emergent adverse events (TEAEs) and treatment
emergent serious adverse events (TESAEs).
RSV, a seasonal virus that typically circulates
in autumn through spring in temperate regions, is the most common
cause of lower respiratory tract infections (LRTI) and the leading
cause of hospitalizations in all infants.1,2,4“These data for
nirsevimab are important as they show a safety and tolerability
profile comparable to the only available preventative option
against lower respiratory tract infections caused by RSV for
preterm infants and those with health conditions,” said Dr. Joseph
Domachowske, Professor of Pediatrics and Professor of Microbiology
and Immunology at the State University of New York, Upstate Medical
Center and MEDLEY trial primary investigator. “Given the typical
RSV season lasts nearly five months, there is a potential advantage
to providing a preventative option that could help protect all
infants with one dose for the entire season.”MEDLEY is the third
pivotal trial to report positive data for nirsevimab. In April,
Sanofi reported that nirsevimab met its primary endpoint of
achieving a statistically significant reduction of LRTI caused by
RSV in healthy preterm and term infants in the Phase 3 MELODY
trial. Coupled with recently published Phase 2b trial results,
MELODY and MEDLEY results are part of a robust body of evidence
demonstrating the potential of nirsevimab to provide RSV protection
to all infants. Results from the MELODY and MEDLEY trials will be
presented at forthcoming scientific congresses and, along with the
Phase 2b results, will form the basis of global regulatory
submissions planned for 2022.
“RSV is the major remaining pediatric infectious
disease with no preventative option available to all infants,” said
Jean-François Toussaint, Global Head of Research and Development,
Sanofi Pasteur. “We believe nirsevimab has the potential to become
an important and innovative routine immunization for all infants –
those born prematurely or at term, healthy or with health
conditions.”
“RSV is the leading cause of hospitalizations in
infants,” said Mene Pangalos, Executive Vice President,
BioPharmaceuticals R&D, AstraZeneca. “These results, combined
with the recent positive efficacy outcome of our MELODY Phase 3
trial and our Phase 2b data, contribute to the body of evidence
demonstrating nirsevimab’s potential to protect all infants against
RSV with one dose. We look forward to sharing the results with
regulators.”
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.5-7 With nirsevimab, the goal is to provide
rapid and direct protection to the infant through a single
immunization.
Nirsevimab is designed to be administered from
birth to infants born during the RSV season or at the season’s
start for infants entering their first RSV season. In contrast
to other options for RSV under development, such as maternal
immunization, the aim of nirsevimab is to offer protection when
needed to all infants entering their first season.
About the Phase 2/3 MEDLEY clinical
trial
MEDLEY is a Phase 2/3, randomized, double-blind,
palivizumab-controlled trial with the primary objective to evaluate
the safety and tolerability of nirsevimab compared to palivizumab
when administered to preterm infants entering their first
respiratory syncytial virus (RSV) season and children with CLD and
CHD entering their first and second RSV season.3 Safety is assessed
by monitoring the occurrence of TEAEs and TESAEs through 360 days
post-dose. Between July 2019 and May 2021 approximately 925 infants
entering their first RSV season were dosed with either nirsevimab
or palivizumab.
The evaluation of nirsevimab was carried out
earlier than anticipated, based on sufficient enrollment, allowing
for the assessment of nirsevimab’s safety and tolerability versus
palivizumab in infants followed through their first RSV season. The
trial is ongoing to collect additional safety data in toddlers with
CLD or CHD dosed prior to the second season. Results from the
MEDLEY trial will be presented at a forthcoming scientific
congress.
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.1,5,8-12
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.8,13,14 Most hospitalizations for RSV occur in otherwise
healthy infants born at term.8,15 Moreover, medically-attended
LRTIs are associated with increased costs to the healthcare
system.16
About nirsevimab
Nirsevimab is an investigational extended
half-life RSV mAb being developed as a passive immunization for the
prevention of LRTI caused by RSV. It is designed to protect all
infants experiencing their first RSV season and infants with
congenital heart disease or chronic lung disease entering their
first and second RSV season.3,17
Nirsevimab is developed with the goal of
providing 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.18 Passive
immunization could offer rapid protection.18
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. |
Media Relations ContactNicolas KressmannTel.: +1
(732) 532-5318Nicolas.Kressmann@sanofi.com |
Investor Relations Contacts ParisEva
Schaefer-JansenArnaud DelepineNathalie Pham Investor
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https://www.cdc.gov/vaccines/vac-
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