RSV Monoclonal Antibody March 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). To protect these people, the U.S. Food and Drug Administration (FDA) approved an injectable monoclonal antibody (mAbs) therapy in 1998.

The U.S. Centers for Disease Control and Prevention (CDC) CDCHAN-00479 stated on November 4, 2022, that eligible high-risk children should receive palivizumab treatment o help prevent RSV-associated hospitalizations according to American Academy of Pediatrics (AAP) guidelines on November 27, 2022. In addition, in June 2021, the AAP strongly supported consideration for using palivizumab in eligible patients during the interseasonal spread of RSV.

In 2021, the World Health Organization (WHO) published its preferred product characteristics of mAbs for passive immunization against ‎RSV‎ disease. In addition, a study published by the journal Vaccine on June 9, 2022, highlighted key considerations for RSV mAbs' global use. 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.

RSV Monoclonal Antibodies

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 4 mAbs, nirsevimab, motavizumab, and palivizumab, that were associated with significant reductions in RSV-related hospitalization, infection, and supplemental oxygen use on children.

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® (nirsevimab) worldwide approval on November 4, 2022. The Biologics License Application (BLA) for nirsevimab was accepted for review by the U.S. FDA on January 5, 2023. The FDA's target action date for its decision is in the third quarter of 2023. In addition, the U.S. CDC presented Nirsevimab to the Advisory Committee on Immunization Practices (ACIP) committee on October 20, 2022.

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 mAbs considered to help prevent RSV disease. MedImmune filed the original BLA on 30 January 2008 and was reviewed by the FDA's Antiviral Drugs Advisory Committee in June 2010. Subsequently, MedImmune decided to discontinue certain motavizumab development paths and withdraw the prophylaxis BLA from the FDA.