RSV Monoclonal Antibody

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Last reviewed
May 24, 2023
Content Overview
RSV monoclonal antibody therapies are U.S. FDA, Canada, UK, and Europe approved in May 2023.

RSV Monoclonal Antibody May 2023

Respiratory syncytial virus (RSV) is a leading cause of respiratory disease in children and older adults, says the U.S. Centers for Disease Control and Prevention (CDC). In 2021, the World Health Organization (WHO) published its preferred product characteristics of mAbs for passive immunization against ‎RSV‎ disease. In addition, to help protect infants from RSV infections, the U.S. Food and Drug Administration (FDA) approved an injectable monoclonal antibody (mAbs) therapy in 1998, and newer mAbs were approved in 2023.

RSV Monoclonal Antibody 2023

The U.S. CDC Advisory Committee on Immunization Practices (ACIP) digital and real-world meeting on February 23, 2023, reviewed the following presentations: Introduction, Dr. S Long; Cost-effectiveness analysis for nirsevimab – CDC model, Dr. David Hutton; Cost-effectiveness analysis for nirsevimab – Comparison to manufacturer model, Dr. Ismael Ortega Sanchez; Evidence to Recommendations framework for nirsevimab, Dr. Jefferson Jones; Clinical considerations for nirsevimab, Dr. Jefferson Jones; Safety and Efficacy of RSV Bivalent PreF Maternal Vaccine, Dr. Iona Munjal; Workgroup considerations, Dr. Katherine Fleming-Dutra. Dr. Hutton concluded Nirsevimab might be cost-effective.

The JAMA Network published an Original Investigation on February 17, 2023: a systematic review and network meta-analysis of 14 randomized clinical trials assessing the efficacy and safety of four mAbs, nirsevimab, motavizumab, and palivizumab, that were associated with significant reductions in RSV-related hospitalization, infection, and supplemental oxygen use on children. According to the U.S. NIH, these antibodies are produced by cell lines or clones obtained from animals that have been immunized with the substance that is the disease.

The U.S. CDC CDCHAN-00479 stated on November 4, 2022, that eligible high-risk children should receive palivizumab treatment o help prevent RSV-associated hospitalizations. In addition, the American Academy of Pediatrics (AAP) guidelines were published on November 27, 2022. Previously, in June 2021, the AAP strongly supported consideration for using palivizumab in eligible children during the interseasonal spread of RSV. In addition, a study published by the journal Vaccine on June 9, 2022, highlighted critical considerations for RSV mAbs' global use.

AstraZeneca and Sanofi co-developed Beyfortus® (Nirsevimab), a single-dose, long-acting antibody designed to protect infants through their first RSV season. The European Commission granted Beyfortus worldwide approval on November 4, 2022, followed by the U.K. and Canada. The FDA's target action date for its decision is in the third quarter of 2023.

AstraZeneca's Synagis® (Palivizumab) multi-dose injectable RSV antibody is limited to high-risk infants and provides one-month protection, requiring five injections to cover an RSV season. The U.S. FDA (1998), Canada, Japan, Israel, and the U.K. approved Palivizumab (Synagis) to protect at-risk patients (premature babies, infants) against RSV. Synagis continues to build on 25 years of real-world usage with a new cost-effectiveness analysis. This analysis (Feb. 2023) is the first to incorporate the International Risk Scoring Tool, which helps clinicians identify pre-term infants with the highest risk of hospitalization.

Motavizumab is a discontinued investigational mAb considered to help prevent RSV disease. MedImmune filed the original BLA in January 2008. Subsequently, MedImmune decided to discontinue motavizumab development.

RSV Vaccine Candidates

RSV vaccine news is updated in May 2023.

RSV Seasonality

Data related to RSV seasonality is posted at this link.

RSV Monoclonal Antibody New 2023

May 15, 2023 - Real-world data from the Phase IIIb clinical trial showed that nirsevimab reduced the incidence of hospitalizations due to severe RSV-related LRTD by 75.71% and demonstrated a reduction of 58.04% in the incidence of all-cause LRTD hospitalization compared to infants who received no RSV intervention.

May 12, 2023 - Sanofi announced Nirsevimab delivers an 83% reduction in RSV infant hospitalizations in a real-world clinical trial setting.

April 24, 2023 - Health Canada approves BEYFORTUS™ (nirsevimab) to prevent infant RSV disease.

March 30, 2023 - The UKHSA reported the overall hospital admission rate for RSV remained low at 0.20 per 100,000 In week #12.