Beyfortus (nirsevimab)

To prevent respiratory syncytial virus (RSV) lower respiratory tract disease Press Release Drug Trials Snapshot

FDA Approval: 7/17/2023

Research Synopsis

  • - The drug Beyfortus (nirsevimab) is a monoclonal antibody designed for the prevention of respiratory syncytial virus (RSV) infections, particularly in infants.
  • Nirsevimab provides long-lasting protection against RSV with a single dose, making it more convenient compared to prior treatments like palivizumab, which requires monthly injections.
  • Clinical trials have demonstrated that nirsevimab significantly reduces the incidence of RSV infections by 70.1% and hospitalizations by 78.4% in preterm infants compared to placebo.
  • Nirsevimab has shown a favorable safety profile, with no major safety concerns reported in various studies across different infant populations.
  • Studies indicate that nirsevimab could provide herd immunity effects, benefitting not only infants but also older adults by potentially reducing RSV transmission.
  • The accessibility of nirsevimab is crucial, with discussions around its integration into healthcare systems, especially in low- and middle-income countries where RSV is prevalent.
  • The introduction of nirsevimab poses potential health equity issues based on reimbursement pathways, with a vaccine-like approach being identified as a more effective means to increase coverage among lower-income families.
  • Ongoing research emphasizes the importance of understanding RSV's molecular diversity and resistance development to ensure effective treatments and preventive measures remain viable as the virus evolves.
  • Overall, recent findings position nirsevimab as a promising candidate for broader RSV prophylaxis strategies and highlight the need for further research to address existing knowledge gaps in global RSV epidemiology.

Related articles

Research articles about Beyfortus (nirsevimab)

Beyfortus (nirsevimab)

Global molecular diversity of RSV - the "INFORM RSV" study.

London, UK

2 hours ago

1 Received

  • Respiratory syncytial virus (RSV) is a significant cause of severe respiratory illness in infants, and the INFORM study aims to explore the global molecular diversity of RSV through a comprehensive clinical research approach.
  • The study covers 17 countries across all continents and plans to analyze over 4,000 RSV-positive samples over five years to identify geographical and temporal molecular patterns.
  • Findings will help assess resistance to new treatments and create a database and repository for RSV strains to aid future research and interventions.

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Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants.

London, UK

2 hours ago

1 Received

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$100 - $150

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Respiratory Syncytial Virus and Human Metapneumovirus Infections in Three-Dimensional Human Airway Tissues Expose an Interesting Dichotomy in Viral Replication, Spread, and Inhibition by Neutralizing Antibodies.

London, UK

2 hours ago

1 Received

  • RSV and HMPV are major causes of respiratory infections, especially in children, the elderly, and immunocompromised individuals, with a lack of approved treatments for HMPV and only palivizumab available for high-risk infants with RSV.* -
  • Using 3-D human airway tissues, the study found RSV spreads more efficiently than HMPV and predominantly infects apical ciliated cells, while each virus displays different characteristics in their infection processes.* -
  • Both palivizumab and nirsevimab inhibit RSV effectively, with nirsevimab showing greater potency, whereas 54G10 inhibited HMPV entry but not its spread, highlighting the distinct mechanisms of infection and treatment responses for each

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Single-dose nirsevimab prevents RSV infection.

London, UK

2 hours ago

1 Received

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Distinct patterns of within-host virus populations between two subgroups of human respiratory syncytial virus.

London, UK

2 hours ago

1 Received

  • Human respiratory syncytial virus (RSV) causes significant lower respiratory infections in young children, yet its within-host diversity remains poorly understood.
  • Analysis of deep-sequencing data from 319 nasopharyngeal swabs showed that RSV-B has lower overall genetic diversity but greater variability within individual hosts compared to RSV-A.
  • Key mutations in the F protein of RSV-B may lead to resistance against emerging RSV treatments, highlighting the need to monitor these viral changes for effective vaccination strategies.

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Bringing Preventive RSV Monoclonal Antibodies to Infants in Low- and Middle-Income Countries: Challenges and Opportunities.

London, UK

2 hours ago

1 Received

  • Respiratory syncytial virus (RSV) is a major cause of severe respiratory infections in infants, especially those under 3 months old and in low-income countries where deaths are more common.
  • Currently, there are no approved vaccines for RSV in mothers or infants, but developing an affordable monoclonal antibody (mAb) could help fill this gap and protect vulnerable infants.
  • Next-generation mAbs like nirsevimab are promising because they only require a single dose for long-lasting protection, but integrating these solutions into healthcare systems and collaborating with organizations like WHO and Gavi is crucial for success in low and middle-income countries.

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The race to make vaccines for a dangerous respiratory virus.

London, UK

2 hours ago

1 Received

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Coadministration of Anti-Viral Monoclonal Antibodies With Routine Pediatric Vaccines and Implications for Nirsevimab Use: A White Paper.

London, UK

2 hours ago

1 Received

  • Routine childhood vaccinations protect against serious diseases, but some viral diseases like RSV lack effective vaccines.
  • Nirsevimab is a new monoclonal antibody being considered for RSV prevention in infants, which may be integrated into existing vaccine schedules.
  • Evidence from past use of palivizumab, another mAb for RSV, supports the safe coadministration of antiviral mAbs with routine vaccines, demonstrating no adverse effects on vaccine efficacy.

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COVID-19, Influenza and RSV: Surveillance-informed prevention and treatment - Meeting report from an isirv-WHO virtual conference.

London, UK

2 hours ago

1 Received

  • The ISIRV and WHO held a joint virtual conference from October 19-21, 2021, primarily focusing on the global response to the SARS-CoV-2 pandemic but also addressing influenza and RSV treatment and prevention.
  • Key discussions included potential therapeutics for SARS-CoV-2, such as the JAK inhibitor baricitinib, IL-6R inhibitor tocilizumab, and various monoclonal antibodies targeting the virus's spike protein.
  • The conference also highlighted advancements in RSV treatments like the monoclonal antibody nirsevimab and an Ad26.RSV vaccine, as well as the expanded role of the WHO in global influenza surveillance and response during the pandemic.

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Breakthrough therapy designation of nirsevimab for the prevention of lower respiratory tract illness caused by respiratory syncytial virus infections (RSV).

London, UK

2 hours ago

1 Received

  • Respiratory syncytial virus (RSV) significantly impacts infants and young children, with palivizumab being the current preventive treatment requiring monthly injections, while new treatments like nirsevimab (MEDI8897) are being developed.
  • Nirsevimab is a long-lasting monoclonal antibody designed to offer protection against RSV infections for an entire season with just one dose, potentially improving upon existing therapies.
  • Clinical trials of nirsevimab show promise for its use in various infant populations, but the need for effective RSV vaccines and treatments continues even if nirsevimab gains approval.

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Potential Impact of Nirsevimab on RSV Transmission and Medically Attended Lower Respiratory Tract Illness Caused by RSV: A Disease Transmission Model.

London, UK

2 hours ago

1 Received

  • - The study evaluates the effectiveness of nirsevimab, a monoclonal antibody, in preventing respiratory syncytial virus (RSV) infections in infants during their first RSV season in the USA.
  • - A model was created to predict outcomes based on two scenarios: one with no effect on virus transmission and another predicting a 50% reduction in viral shedding, showing that universal immunization can significantly reduce RSV-related medical visits.
  • - Results indicate that nirsevimab could greatly benefit infants while also providing some herd immunity effects, especially for infants under two years and older adults, highlighting its potential effectiveness based on its mechanism of action.

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$100 - $150

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Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants.

London, UK

2 hours ago

1 Received

  • Respiratory syncytial virus (RSV) significantly affects infants, leading to serious lower respiratory infections, and nirsevimab is a monoclonal antibody designed to combat this infection.
  • In a study involving 1490 infants, those receiving nirsevimab showed a 74.5% effectiveness in preventing medically attended RSV-associated infections compared to the placebo group.
  • The results indicate that while nirsevimab reduced the incidence of RSV-related complications, the overall rate of serious adverse events was similar between the nirsevimab and placebo groups, suggesting a reasonable safety profile for the treatment.

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Safety of Nirsevimab for RSV in Infants with Heart or Lung Disease or Prematurity.

London, UK

2 hours ago

1 Received

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RSV Prevention in All Infants: Which Is the Most Preferable Strategy?

London, UK

2 hours ago

1 Received

  • Respiratory syncytial virus (RSV) poses significant health risks to infants, often leading to hospitalizations and contributing to recurrent wheezing and asthma-like symptoms, making it a global health priority.
  • Current preventive measures mainly involve the monoclonal antibody palivizumab, which is only available to a limited group of high-risk infants, leaving the majority unprotected.
  • This review explores broader immunization strategies, focusing on maternal immunization and long-acting monoclonal antibodies as viable options to protect all infants during their first RSV season.

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Nirsevimab: a promising therapy for RSV.

London, UK

2 hours ago

1 Received

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A systematic review on global RSV genetic data: Identification of knowledge gaps.

London, UK

2 hours ago

1 Received

  • RSV is a significant health issue, and understanding its geographical and temporal dynamics can help track resistance against developing treatments.
  • A systematic review analyzed 78 studies and nearly 13,000 RSV sequences published between 2015 and 2020, highlighting that many studies lacked data from low- and middle-income countries.
  • The review identified three major knowledge gaps: the need for whole-genome data to understand RSV evolution, more data from LMICs, and the importance of global surveillance programs to assess monoclonal antibody effectiveness.

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Phase 3 clinical trial results for nirsevimab: Is it time to consider population-level RSV immunoprophylaxis?

London, UK

2 hours ago

1 Received

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Inequalities in Health Impact of Alternative Reimbursement Pathways for Nirsevimab in the United States.

London, UK

2 hours ago

1 Received

  • * Different reimbursement pathways were analyzed, showing that a vaccine-like approach could cover 32% more infants compared to a pharmaceutical pathway.
  • * The vaccine pathway not only reduces hospitalizations and emergency room visits significantly (30% and 39% overall, respectively) but also offers greater benefits to publicly insured infants and those from lower-income families.

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Nirsevimab reduces medically attended RSV-associated lower respiratory tract infection and hospitalisations in healthy pre-term infants.

London, UK

2 hours ago

1 Received

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