FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of July 2023
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
Beyfortus approved in US for infant RSV prevention
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
For details on how to contact the Investor
Relations Team, please click here.
For Media contacts, click here.
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.
S127-S132. Doi:10.1067/s0022-
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://www.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
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
17 July 2023
|
|
By: /s/
Adrian Kemp
|
|
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Name:
Adrian Kemp
|
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Title:
Company Secretary
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