Press Release: CHMP recommends approval of Beyfortus® (nirsevimab)
for prevention of RSV disease in infants
CHMP recommends approval of Beyfortus® (nirsevimab) for
prevention of RSV disease in infants
- Recommendation
is based on the Beyfortus clinical trial program which demonstrated
protection against medically attended lower respiratory tract
infection caused by RSV with a single dose during the RSV
season
- If
approved, Beyfortus would be the first broadly protective
option for newborns and infants
Paris,
September
16, 2022. The
European Medicines Agency’s Committee for Medicinal Products for
Human Use (CHMP) has adopted a positive opinion for Beyfortus®
(nirsevimab) for the prevention of respiratory syncytial virus
(RSV) lower respiratory tract disease in newborns and infants
during their first RSV season. If approved, Beyfortus would be the
first and only single-dose passive immunization 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.
Jean-François ToussaintGlobal
Head of Research and Development Vaccines, Sanofi “Today’s positive
CHMP opinion is one of the most significant public health
achievements in RSV in decades and has the potential to alleviate
the enormous physical and emotional burden that RSV can place on
families and healthcare systems. With this endorsement, we are one
step closer to achieving our goal of protecting all infants against
RSV with a single dose.”
Iskra
ReicExecutive Vice President, Vaccines and Immune
Therapies, AstraZeneca“This positive CHMP opinion underscores
Beyfortus’ potential as a ground-breaking, first-in-class passive
immunization that could transform the medical community’s approach
to RSV prevention in infants.”
The CHMP based its positive opinion on results
from the Beyfortus clinical development program, including the
Phase 3 MELODY, Phase 2/3 MEDLEY, and Phase 2b trials.1-8 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. 1-6 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.7-8
RSV is the most common cause of LRTIs and a
leading cause of hospitalization in all infants, with most
hospitalizations occurring in infants born healthy and at term.9-13
RSV-related direct medical costs, globally — including hospital,
outpatient and follow-up care — were estimated at €4.82 billion in
2017.14 Currently there is no preventative option available for all
infants and treatment is limited to symptomatic relief.15,16
About
Beyfortus
Beyfortus® (nirsevimab), an investigational
long-acting antibody designed for all infants for protection
against RSV disease from birth through their first RSV season with
a single dose, is being 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 disease.17
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 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.
Beyfortus has been granted designations to
facilitate expedited development by several major 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 Beyfortus was evaluated under an accelerated
assessment procedure by the EMA. Beyfortus has not been approved by
any regulatory authority.
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.3,4 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.3 The subsequent Phase 3 study, MELODY, applied the
recommended dosing regimen.2
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.1,2 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.1,2 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.5 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 2022.1,5
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.7,8 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.7,8 Serum levels of nirsevimab 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.7 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.1-8 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 LRTI, including
bronchiolitis and pneumonia, in infants.9 It is also a leading
cause of hospitalization in all infants, with most hospitalizations
for RSV occurring in healthy infants born at term.10-13 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
2017.14
About SanofiWe are an innovative global
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