TIDMAZN
RNS Number : 2865G
AstraZeneca PLC
17 July 2023
17 July 2023
Beyfortus approved in the US for the prevention of RSV
lower respiratory tract disease in infants
First preventive option specifically designed to protect
the broad infant population through its first RSV season
Across all clinical endpoints, a single dose of Beyfortus
delivered consistent and sustained efficacy against RSV disease vs
placebo
AstraZeneca and Sanofi's Beyfortus (nirsevimab) has been
approved in the US for the prevention of respiratory syncytial
virus (RSV) lower respiratory tract disease (LRTD) in newborns and
infants born during or entering their first RSV season, and for
children up to 24 months of age who remain vulnerable to severe RSV
disease through their second RSV season. Beyfortus will be
available in the US ahead of the upcoming 2023-2024 RSV season.
The approval by the Food and Drug Administration (FDA) follows
the unanimous vote by the Antimicrobial Drugs Advisory Committee
(AMDAC) on the favourable benefit-risk profile of Beyfortus, and
was based on the extensive clinical development programme for
Beyfortusspanning three pivotal late-stage clinical trials. Across
all clinical endpoints, a single dose of Beyfortus demonstrated
consistent efficacy against RSV LRTD extending through five months,
the duration of a typical RSV season.(1-4)
Beyfortus is the first preventive option approved to protect a
broad infant population, including those born healthy at term, or
preterm, or with specific health conditions that make them
vulnerable to severe RSV disease. The single dose can be flexibly
administered at the beginning of the RSV season or at birth for
those born during the RSV season.
Iskra Reic, Executive Vice President, Vaccines and Immune
Therapies, AstraZeneca, said: "Beyfortus represents an opportunity
for a paradigm-shift in preventing serious respiratory disease due
to RSV across a broad infant population in the US. The science that
Beyfortus is built on demonstrates AstraZeneca's continued
leadership in addressing the needs of the most vulnerable
populations and reducing the burden on healthcare systems."
Thomas Triomphe, Executive Vice President, Vaccines, Sanofi,
said: "Today's approval marks an unprecedented moment for
protecting infant health in the U.S., following an RSV season that
took a record toll on infants, their families, and the U.S.
healthcare system. Beyfortus is the only monoclonal antibody
approved for passive immunisation to provide safe and effective
protection for all infants during their first RSV season. I am
proud that, by prioritising this potential game-changer, we are now
about to bring Beyfortus to American families."
RSV is the leading cause of hospitalisation for infants under
the age of one in the US, averaging 16 times higher than the annual
rate for influenza.(5,6) Each year, an estimated 590,000 RSV
disease cases in infants under one require medical care, including
physician office, urgent care, emergency room visits and
hospitalisations.(7)
Beyfortus was generally well tolerated with a favourable safety
profile that was consistent across all clinical trials. The overall
rates of adverse events were comparable between Beyfortusand
placebo and the majority of adverse events were mild or moderate in
severity. The most common adverse events were rash and injection
site reactions.(1-4)
Beyfortus was approved in the European Union in October 2022 for
the prevention of RSV LRTD in newborns and infants during their
first RSV season. Regulatory applications are also currently under
review in China, Japan and several other countries.
Notes
RSV
RSV is a very contagious virus that can lead to serious
respiratory illness for infants, according to the Centers for
Disease Control and Prevention (CDC). RSV symptoms can include
runny nose, coughing, sneezing, fever, decrease in appetite, and
wheezing.(8) Two out of three infants are infected with RSV during
their first year of life and almost all infants are infected by
their second birthday.(8,9) In the US, RSV is the leading cause of
hospitalisation in infants under 12 months, averaging 16 times
higher than the annual rate for influenza.(5,6) Approximately 75%
of infants hospitalised for RSV were born at term with no
underlying conditions in a study conducted from 2014-2015.(10) Each
year in the US, an estimated 590,000 RSV disease cases in infants
under one require medical care, including physician office, urgent
care, emergency room visits and hospitalisations.(7)
Beyfortus
Beyfortus (nirsevimab) is a single dose long-acting antibody,
developed and commercialised in partnership by AstraZeneca and
Sanofi using AstraZeneca's YTE technology. It is designed to
protect infants born during or entering their first RSV season and
for children up to 24 months of age who remain vulnerable to severe
RSV disease through their second RSV season. Beyfortus,provided
directly to newborns and infants as a single dose, offers rapid
protection via an antibody to help prevent LRTD caused by RSV,
without requiring activation of the immune system. Beyfortus
administration can be timed to the start of the RSV season.(11)
Beyfortushas been granted regulatory designations to facilitate
expedited development by several major regulatory agencies around
the world. These include Breakthrough Therapy Designation and
Priority Review 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 (PRIME) scheme; 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).
Pivotal clinical trials
The Phase IIb (Trial 03) study was a randomised,
placebo-controlled trial designed to measure the efficacy of
Beyfortus against medically attended (MA) Lower Respiratory Tract
Infection (LRTI) through 150 days post-dose. Healthy preterm
infants of 29 to less than 35 weeks' gestational age were
randomised (2:1) to receive a single 50mg intramuscular injection
of Beyfortusor placebo regardless of weight.(3,12)
The Beyfortusdosing regimen was determined based on further
exploration of the Phase IIb data and was used in subsequent trials
as a single 50 mg dose for those who weigh less than 5 kg, or a
single 100 mg dose for those who weigh 5 kg or greater.(3,12)
The MELODY Phase III study (Trial 04) was a randomised,
double-blind, placebo- controlled trial conducted across 21
countries designed to determine efficacy of Beyfortus against
medically attended LRTI due to through 150 days after dosing,
versus placebo, in healthy term and late preterm infants (35 weeks
gestational age or greater) entering their first RSV
season.(1,2,12)
MEDLEY (Trial 05) was a Phase II/III, randomised, double-blind,
Synagis-controlled trial with the primary objective of assessing
safety and tolerability for Beyfortusin preterm infants of less
than 35 weeks gestational age and infants with congenital heart
disease (CHD) and/or chronic lung disease of prematurity (CLD)
eligible to receive Synagis.(4,12) Between July 2019 and May 2021 a
total of 925 infants entering their first RSV season were
randomised to receive Beyfortus or Synagis. Safety was assessed by
monitoring the occurrence of adverse events through 360 days
post-dose. Serum levels of Beyfortus following dosing (on day 151)
in this trial were comparable with those observed in the MELODY
Phase III trial, indicating similar protection in this population
to that in the healthy term and late preterm infants is likely.
Data were published in the New England Journal of Medicine (NEJM)
in March 2022.(4,12)
The safety profile of Beyfortus was similar to Synagis in the
MEDLEY Phase II/III trial and consistent with the safety profile in
healthy term and preterm infants studied in the MELODY and Phase
IIb trials. While uncommon, the most reported adverse reactions
were: rash 14 days post-dose, (the majority of which were mild to
moderate; non-serious injection site reactions within 7 days
post-dose. (1,2,4,12)
The results of MELODY, MEDLEY Phase II/III and the Phase IIb
trials demonstrate that a single dose of nirsevimab helps protect
infants during their first RSV season against RSV disease. This
broad infant population includes healthy term, late preterm and
preterm infants, as well as infants with specific health conditions
that make them vulnerable to severe RSV disease.(1-4,12)
These trials formed the basis of regulatory submissions which
began in 2022.
Results from the MELODY Phase III trial (Trial 04)
The primary endpoint of the MELODY Phase III trial was met,
reducing the incidence of medically attended LRTI, such as
bronchiolitis or pneumonia, caused by RSV by 74.9%
(95% CI 50.6, 87.3; P<0.001) compared to placebo.(1,2)
Observed events were 1.2% in treatment arm vs 5% in placebo arm.
The efficacy of Beyfortus against the secondary endpoint of
hospitalisation was 60.2% (95% CI: -14.6, 86.2). Observed events
were 0.6% in treatment arm vs 1.6% in placebo arm. Between July
2019 and March 2020, 1,490 infants were randomised to receive
either nirsevimab or placebo at the RSV season start Initial data
from the MELODY Primary Cohort were published in NEJM in March 2022
(12)
Results from the Phase IIb trial (Trial 03)
The primary endpoint of the Phase IIb study was met, reducing
the incidence of medically attended LRTI caused by RSV by 70.1%
(95% CI: 52.3, 81.2) compared to placebo. Observed events were 2.6%
in treatment arm vs 9.5% in placebo arm. Between November 2016 and
December 2017, 1,453 infants were randomised (Beyfortus, n=969;
placebo, n=484) at the RSV season start. Research was conducted by
AstraZeneca in both hemispheres, at 164 sites in 23 countries. Data
were published in NEJM in July 2020.(3,12)
In a prespecified secondary endpoint, Beyfortusreduced medically
attended RSV LRTI with hospitalisation by 78.4% (95% CI 51.9, 90.3)
versus placebo. Observed events were 0.8% in treatment arm vs 4.1%
in placebo arm.(3,12) A post-hoc analysis of the Phase IIb study
that applied the recommended 50 mg dose in a subgroup of infants
weighing less than 5 kg showed the efficacy of Beyfortus against
medically attended RSV LRTI and medically attended RSV LRTI with
hospitalisation was 86.2% (95% CI 68.0, 94.0) and
86.5% (95% CI 53.5, 96.1), respectively.(12)
Sanofi Alliance
In March 2017, AstraZeneca and Sanofi announced an agreement to
develop and commercialise nirsevimab. Under the terms of the
agreement, AstraZeneca leads development and manufacturing
activities, and Sanofi leads commercialisation activities and
records revenue. The two companies share costs and profits in all
territories except the US. AstraZeneca's revenue from the agreement
is reported as Alliance Revenue and Collaboration Revenue in the
Company's financial statements. Following a revision to the
profit-sharing arrangement relating to the development and
commercialisation of nirsevimab in the US between AstraZeneca,
Sanofi and Sobi, Sobi has entered into a direct relationship with
Sanofi, replacing the previous participation agreement with
AstraZeneca entered into in November 2018 .
AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led
biopharmaceutical company that focuses on the discovery,
development, and commercialisation of prescription medicines in
Oncology, Rare Diseases, and BioPharmaceuticals, including
Cardiovascular, Renal & Metabolism, and Respiratory &
Immunology. Based in Cambridge, UK, AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow the
Company on Twitter @AstraZeneca .
Contacts
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References
1. Muller WJ, et al. Nirsevimab for Prevention of RSV in Term
and Late-Preterm Infants. N Engl J Med. April 5, 2023. DOI:
10.1056/NEJMc2214773
2. Hammitt LL, 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.
3. Griffin P, MD et al. Single-Dose Nirsevimab for Prevention of
RSV in Preterm Infants. N Engl J Med. 2020;383: 415-425. DOI:
10.1056/NEJMoa1913556.
4. 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).
5. Leader S, Kohlhase K. Recent trends in severe respiratory
syncytial virus (RSV) among US infants, 1997 to 2000. J Pediatr.
2003;143(5 Suppl):S127-S132. Doi:10.1067/s0022-
3476(03)00510-9.
6. Zhou H, et al. Hospitalizations associated with influenza and
respiratory syncytial virus in the United States, 1993-2008. Clin
Infect Dis. 2012 ;54 :1427-1436.
7. Rainisch G, et al. Estimating the impact of multiple
immunization products on medically- attended respiratory syncytial
virus (RSV) infections in infants. Vaccine. 2020;38(2):251-257.
8. Centers for Disease Control and Prevention. RSV in Infants
and Young Children. October 28, 2022. https://
www.cdc.gov/rsv/high-risk/infants-young-children.html. Accessed
July 2023.
9. Walsh, EE. Respiratory Syncytial Virus infection: an illness
for all ages. Clin Chest Med. 2017; 38(1):29-36.
10. Esposito S, et al. RSV Prevention in All Infants: Which Is
the Most Preferable Strategy? Front Immunol. 2022; 13: 880368. doi:
10.3389/fimmu.2022.880368.
11. Centers for Disease Control and Prevention. Vaccines &
Immunizations. August 18, 2017. https: //w ww
.cdc.gov/vaccines/vac-gen/immunity-types.htm. Accessed July
2023.
12. US FDA. Beyfortus (nirsevimab-alip) Prescribing
Information.
Adrian Kemp Company Secretary AstraZeneca PLC
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