The EU CHMP recommends approval of Beyfortus (nirsevimab) for the prevention of RSV disease in infants

*For medical professionals only

▶ The EU CHMP recommends approval of Beyfortus (nirsevimab) for the prevention of RSV disease in infants

· The approval opinion is based on the results of Beyfortus clinical trials confirming that a single dose of Beyfortus during the RSV epidemic season can effectively prevent lower respiratory tract infections caused by RSV that require medical attention

· Once approved, Beyfortus will be the first RSV prevention tool that can be widely used in newborns and infants

(Paris, 16 September 2022)

The European Medicines Agency's (EMA) Committee on Medicinal Products for Human Use (CHMP) adopted a positive opinion on Beyfortus (nirsevimab) recommending the approval of Beyfortus for use in newborns and infants to help prevent RSV lower respiratory tract infections when the first respiratory syncytial virus (RSV) season

Jean-François Toussaint, head of global R&D for Sanofi vaccines, said:

"Today's positive opinion from CHMP is one of the most important public health achievements in the field of RSV in decades, and promises to alleviate the enormous physical and psychological burden that

"CHMP's positive comments underscore Beyfortus' potential to become a landmark and pioneering passive immune agent and revolutionize the way

CHMP's positive opinions are based on the results of Beyfortus clinical studies, including Phase III MELODY, Phase II/III MEDLEY, and Phase IIb Clinical Studies ^1-8

Respiratory syncytial virus is the most common cause of lower respiratory tract infections and the leading cause of infant hospitalization worldwide, with most hospitalizations occurring in healthy term ^infants9-13

About Beyfortus

Beyfortus (nirsevimab), an in-research long-acting monoclonal antibody designed for all infants to protect them from RSV disease from birth to the first RSV epidemic season, was developed by Sanofi and AstraZeneca through a single dose

Beyfortus directly helps prevent RSV-related lower respiratory tract infections by giving antibodies to newborns and infants, and unlike active immune mechanisms that require activation of the human immune system, monoclonal antibodies provide timely, rapid, and immediate immune ^protection17

In March 2017, Sanofi and AstraZeneca announced an agreement

Beyfortus has been accredited

About clinical research

The Phase IIb clinical study is a randomized, placebo-controlled study evaluating the effectiveness

The MELODY study is a randomized, placebo-controlled, phase III clinical study conducted in 21 countries to assess the effectiveness of healthy late preterm and term infants (gestational age ≥35 weeks) in preventing RSV-associated lower respiratory tract infections requiring consultation compared with placebo within 150 days of injection of Beyfortus at the time of entering the first RSV epidemic season, with study endpoints confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR)^1,2

The results of the Beyfortus-related clinical study included a pre-set pooled analysis of the Phase III MELODY study and the recommended dose usage for the Phase IIb clinical study
.

The results of the analysis showed that Beyfortus reduced the risk of developing a visitable lower respiratory tract infection (e.
g.
, bronchitis and pneumonia) after term and preterm infants entered the first RSV epidemic season, by 79.
5% (95% CI 65.
9, 87.
7); P<0.
0001)⁵
.

In the pooled analysis, healthy preterm and term infants were injected with the recommended dose of Beyfortus
according to body weight.

The results found that at 151 days, Beyfortus was effective in reducing the hospitalization rate of RSV-related lower respiratory tract infections in healthy preterm and term infants at recommended doses to 77.
3% (95% CI 50.
3, 89.
7; P<0.
001).


The findings were published in the New England Journal of Medicine in March ^20221,5
.

MEDLEY is a phase II/III, randomized, double-blind, controlled clinical study with palivizumab, with the primary objective of comparing the safety and tolerability of Beyfortus versus palizumab in preterm infants, infants with congenital heart disease, and/or infants with chronic lung ^disease7,8
.

Between July 2019 and May 2021, approximately 918 infants entering the first RSV epidemic season were randomly assigned to the Beyfortus or Palivizumab group with a single dose of 50 mg intramuscular injection (infants weighing < 5 kg) or 100 mg dose (infants weighing ≥ 5 kg
).

Within 360 days after injection, the safety is assessed by monitoring the incidence of treatment of sudden adverse events (TEAEs) and treatment of sudden serious adverse events (TESAEs)^7,8
.

The serum concentration of nirsevimab in this study (day 151) was comparable to the results of the phase III MELODY study, suggesting that the protective effect of nirsevimab in this population and healthy term and late preterm infants may be ^similar7
.

The findings were published in the New England Journal of Medicine in
March 2022.

Based on the results of MELODY Phase III and MEDLEY Phase II/III as well as Phase IIb clinical studies, injecting a single dose of Beyfortus provides sustained protection for all infants throughout the RSV epidemic season ^1-8
.

All infants include premature babies, healthy late preterm and term infants, and babies
with special health conditions.

The results of these studies are the cornerstone of the data submitted to regulators starting in 2022
.

About respiratory syncytial virus (RSV)

Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections in infants, including bronchiolitis and pneumonia9
.

RSV is also the leading cause of infant hospitalization worldwide, and most hospitalizations occur in healthy term ^infants10-13
.

In 2019, there were approximately 33 million cases of RSV-related acute lower respiratory tract infections among children under 5 years of age worldwide, resulting in more than 3 million hospitalizations and an estimated 26,300 children dying in ^hospitals18
.

Direct medical costs associated with RSV (including inpatient, outpatient and follow-up care) worldwide were estimated at €4.
82 billion in 201714
.

About Sanofi

Sanofi is a leading global innovative pharmaceutical and health company
.

Our mission is to pursue the wonders of science and bring life to life
.

With a footprint in more than 100 countries around the world, Sanofi is committed to transforming medical practices that make the impossible possible
.

We provide potentially life-changing healthcare solutions and vaccines against deadly diseases to people around the world, while placing sustainability and social responsibility at the heart of
our majestic strategy.

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.

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.

Be sure to consult a healthcare professional for all matters involving medical care
.

References

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Estimated Burden of Community-Onset Respiratory Syncytial Virus-Associated Hospitalizations Among Children Aged <2 Years in the United States, 2014-15.
J Pediatric Infect Dis Soc.
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14.
Zhang S, et al.
Cost of Respiratory Syncytial Virus-Associated Acute Lower Respiratory Infection Management in Young Children at the Regional and Global Level: A Systematic Review and Meta-Analysis.
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Accessed September 2022.

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Li Y, et al.
Global, regional, and national disease burden estimates of acute lower respiratory infections due to respiratory syncytial virus in children younger than 5 years in 2019: a systematic analysis.
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