Nirsevimab reduced respiratory syncytial virus
infections requiring medical care in healthy premature infants in
Phase 2b trial
- Nirsevimab reduced respiratory syncytial virus (RSV) lower
respiratory tract infections by 70 percent and related
hospitalizations by 78 percent1
- Results published in New England Journal of Medicine
- The investigative immunization demonstrated sustained
protection across a typical five-month RSV season with a single
dose1
- Sanofi will host a nirsevimab R&D investor event today at 5
p.m. CET/11 a.m. ET
PARIS – July 30, 2020 –
Detailed results from the positive Phase 2b trial for nirsevimab
showed a significant reduction in medically attended lower
respiratory tract infections (LRTI), mainly bronchiolitis and
pneumonia, and hospitalizations caused by respiratory syncytial
virus (RSV) in healthy preterm infants.
Published in the New England Journal of
Medicine, results from this trial demonstrate for the first time
that a single dose monoclonal antibody can significantly reduce
medically attended RSV LRTI in infants through the full RSV
season.1
“The data for nirsevimab are exciting, as they
highlight the potential for this innovative approach to protect
infants from RSV with just one injection for the entire season,”
said Dr. Joseph Domachowske, study author, Professor of Pediatrics,
Professor of Microbiology and Immunology, and Director of the
Global Maternal-Child and Pediatric Health Program at the SUNY
Upstate Medical University. “Nirsevimab offers the important
potential to reduce hospitalizations and emergency department and
in-office visits, which are a significant burden for healthcare
systems.”
Nirsevimab is an extended half-life RSV
monoclonal antibody (mAb), being developed in partnership with
AstraZeneca as a passive immunization, meaning a protective
antibody is administered directly to an infant to help prevent RSV.
Nirsevimab could set a new standard of care by offering an
innovative immunization for immediate and sustained protection for
all infants during their first RSV season, when they are most at
risk for infection or complication. Ninety percent of all babies
will be infected with RSV before the age of two.1
Phase 2b trial met primary and secondary
endpointsOn the primary endpoint, nirsevimab achieved a
statistically significant 70.1% (95% CI: 52.3%-81.2%) reduction of
medically attended RSV LRTI compared to placebo through 150 days
post-dose. On the secondary endpoint, nirsevimab achieved a 78.4%
(95% CI: 51.9%-90.3%) relative reduction in the incidence of
hospitalizations due to RSV LRTI compared to placebo through 150
days post-dose. The safety profile for nirsevimab was similar to
placebo, with no significant hypersensitivity reactions
observed.12
“It’s encouraging to see from these data that
serious complications from RSV can be reduced in healthy preterm
infants,” said John Shiver, Senior Vice President, Global Research
and Development, Sanofi Pasteur. “Up to 80 percent of babies who
are hospitalized from RSV are otherwise healthy with no prior
complications, but currently these infants have no approved
preventative option to protect them.”
A nirsevimab R&D investor event will be held
today at 5 p.m. CET/11 a.m. ET. Sanofi speakers include:
- Thomas Triomphe, Global Head of Sanofi Pasteur
- Su-Peing Ng, Global Head of Medical, Sanofi Pasteur
- Jon Heinrichs, Global Project Head, nirsevimab, Sanofi
Pasteur
- John Shiver, Global Head of Research & Development, Sanofi
Pasteur
Joining
for the the Q&A session:
- Paul Hudson, Chief Executive Officer
- John Reed, Global Head of Research & Development
- Jean-Baptiste de Chatillon, Chief Financial Officer
Additional information about today’s session can
be found
at:https://www.sanofi.com/en/investors/financial-results-and-events/investor-presentations/nirsevimab-presentation
About RSVRSV, a common,
contagious virus that infects the respiratory tract,3 is the most
common cause of bronchiolitis and pneumonia and results in millions
of hospitalizations globally4 in children younger than one year in
the United States.5 Globally, in 2015, there were approximately 33
million cases of acute lower respiratory infections causing more
than three million hospitalizations, and it was estimated that
there were 60,000 in-hospital deaths of children younger than five
years.3 Up to 80 percent of babies who are hospitalized due to RSV
are otherwise healthy.6,7 Moreover, medically-attended LRTIs are
associated with increased costs to the healthcare system.8
Nirsevimab Clinical Trials The
Phase 2b study was conducted by AstraZeneca at 164 sites in 23
countries. Healthy preterm infants of 29–35 weeks’ gestation were
randomized (2:1) to receive a single intramuscular injection of
nirsevimab or placebo. Between November 2016 and December 2017,
1447 infants were dosed (nirsevimab, n=966; placebo, n=481) at the
RSV season start.1
In July 2019, Sanofi and AstraZeneca initiated
pivotal Phase 3 and Phase 2/3 trials to measure the safety and
efficacy of nirsevimab to prevent LRTI caused by RSV in full-term,
healthy late preterm and high-risk babies.6,7 The trials will be
conducted in more than 350 sites across Northern and Southern
Hemispheres.
The full results of the Phase 3 and Phase 2/3
trials are anticipated in 2023.
About NirsevimabNirsevimab is
an extended half-life RSV mAb being developed for the prevention of
LRTI caused by RSV for use in all infants experiencing their first
RSV season and for children with congenital heart disease or
chronic lung disease entering their first and second RSV
season.9,10
Nirsevimab is a passive immunization, whereby an
antibody is given directly to an infant to help prevent RSV, unlike
active immunization, in which a person’s immune system is activated
to prevent or fight infection.11 Passive immunization could offer
immediate protection.
In March 2017, AstraZeneca and Sanofi Pasteur
announced an agreement to develop and commercialize nirsevimab
jointly. Under the terms of the agreement, AstraZeneca leads all
development activity through initial approvals and retains
manufacturing activities and Sanofi Pasteur will lead
commercialization activities. In February 2019, AstraZeneca and
Sanofi Pasteur’s nirsevimab received Breakthrough Therapy
Designation from the US Food and Drug Administration and were
granted access to the PRIority MEdicines (PRIME) scheme by the
European Medicines Agency
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 |
Media Relations Contact Nicolas Kressmann Tel.: +1
732 532 5318 Nicolas.Kressmann@sanofi.com |
Investor
Relations Contact Eva Schaefer-Jansen Tel.: +33 (0)1 53 77
45 45 ir@sanofi.com |
Sanofi Forward-Looking StatementsThis press
release contains forward-looking statements as defined in the
Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements are statements that are not historical
facts. These statements include projections and estimates and their
underlying assumptions, statements regarding plans, objectives,
intentions and expectations with respect to future financial
results, events, operations, services, product development and
potential, and statements regarding future performance.
Forward-looking statements are generally identified by the words
“expects”, “anticipates”, “believes”, “intends”, “estimates”,
“plans” and similar expressions. Although Sanofi’s management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, the uncertainties inherent in research and development,
future clinical data and analysis, including post marketing,
decisions by regulatory authorities, such as the FDA or the EMA,
regarding whether and when to approve any drug, device or
biological application that may be filed for any such product
candidates as well as their decisions regarding labelling and other
matters that could affect the availability or commercial potential
of such product candidates, the fact that product candidates if
approved may not be commercially successful, the future approval
and commercial success of therapeutic alternatives, Sanofi’s
ability to benefit from external growth opportunities, to complete
related transactions and/or obtain regulatory clearances, risks
associated with intellectual property and any related pending or
future litigation and the ultimate outcome of such
litigation, trends in exchange rates and prevailing interest
rates, volatile economic and market conditions, cost
containment initiatives and subsequent changes thereto, and
the impact that COVID-19 will have on us, our customers, suppliers,
vendors, and other business partners, and the financial condition
of any one of them, as well as on our employees and on the global
economy as a whole. Any material effect of COVID-19 on any of
the foregoing could also adversely impact us. This situation is
changing rapidly and additional impacts may arise of which we are
not currently aware and may exacerbate other previously identified
risks. The risks and uncertainties also include the uncertainties
discussed or identified in the public filings with the SEC and the
AMF made by Sanofi, including those listed under “Risk Factors” and
“Cautionary Statement Regarding Forward-Looking Statements” in
Sanofi’s annual report on Form 20-F for the year ended December 31,
2019. Other than as required by applicable law, Sanofi does not
undertake any obligation to update or revise any forward-looking
information or statements. |
1 Adamko DJ, Friesen M. Why does respiratory syncytial virus
appear to cause asthma? Journal of Allergy and Clinical Immunology.
2012;130(1):101-102. doi:10.1016/j.ja ci.2012.05.0242Centers for
Disease Control and Prevention. RSV in Infants and Young
Children.https://www.cdc.gov/rsv/high-risk/infants-young-children.html.
Accessed November 2019.3Shi T, et al. Global, regional, and
national disease burden estimates of acute lower respiratory
infections due to respiratory syncytial virus in young children in
2015: a systematic review and modelling study. Lancet 2017; 390:
946–58.4Plotkin's Vaccines (Seventh Edition), Elsevier, 2018, Pages
943-949; IASR Vol. 39 p207-209: December, 2018
(https://www.niid.go.jp/niid/en/865-iasr/8491-466te.html)5Hall CB,
et al. “The Burden of Respiratory Syncytial Virus Infection in
Young Children,” New England Journal of Medicine. 2009;
360(6):588-98.6Arriola, C, et al. “Estimated Burden of
Community-Onset Respiratory Syncytial Virus–Associated
Hospitalizations Among Children Aged <2 Years in the United
States, 2014–15.” Journal of the Pediatric Infectious Diseases
Society. 2019.7Leistner R, et al. “Attributable Costs of
Ventilator-Associated Lower Respiratory Tract Infection (LRTI)
Acquired on Intensive Care Units: a Retrospectively Matched Cohort
Study.” Antimicrobial Resistance and Infection Control, vol. 2, no.
1, 4 Apr. 2013, p. 13.,
doi:10.1186/2047-2994-2-138Clinicaltrials.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
November 2019.9 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 November
201910 Vaccines & Immunizations.” Centers for Disease Control
and Prevention. August 18, 2017. Accessed October 2019.
https://www.cdc.gov/vaccines/vac-gen/immunity-types.htm
Sanofi (EU:SAN)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024
Sanofi (EU:SAN)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024