FDA to Review a Preventative RSV Treatment Developed for Infant Population


The novel antibody will receive expedited review, according to the FDA, and already has market authorization in the European Union.

The FDA accepted the biologics license application (BLA) for nirsevimab (Beyfortus; AstraZeneca), which is an antibody indicated to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants entering or during their first respiratory syncytial virus (RSV) season, as well as children aged up to 24 months who are vulnerable to severe RSV disease through to their second RSV season. If approved, nirsevimab could be the first single-dose preventative against RSV lower respiratory tract disease for this patient population.

Based on data from the MELODY trial, the study results demonstrated that niresvimab can reduce lower-respiratory tract infections (LRTI), such as bronchiolitis or pneumonia, caused by RSV by 74.5%. These data were published in New England Journal of Medicine in March 2022.

“This decision brings us a step closer to delivering a first-in-class preventative option for a broad infant population in the US,” said Iskra Reic, executive vice president, vaccines and immune therapies, AstraZeneca, in a press release. “If approved, we believe nirsevimab may transform the medical community’s approach to respiratory syncytial virus prevention in infants and we are committed to working with the FDA to support completion of the review as quickly as possible.”

RSV is the leading cause of hospitalization for babies less than 1 year of age, despite 75% of the children being born with no underlying conditions. The CDC reports that is incredibly contagious and may lead to serious illness.

“This year in the US, we’ve seen first-hand how frightening the impact of this respiratory disease is on our patients and how stressful it is on the healthcare system, highlighting the urgency of addressing this problem,” said William Muller, associate professor, pediatrics, Northwestern University Feinberg School of Medicine and scientific director, clinical and community trials, Ann & Robert H. Lurie Children’s Hospital of Chicago, Illinois, US, in the press release.

Nirsevimab was evaluated in a clinical development program that included phase IIb trials, the MELODY phase III trial, and the MEDLEY phase II/III trials, all of which looked at the drug’s use in infants entering their first and second RSV seasons. Specifically, the phase IIb study measured the efficacy of nirsevimab against medically attended LRTI. Further, the MELODY phase III study looked at efficacy of nirsevimab against medically attended LRTI from RSV, and the subsequent MEDLEY trial assessed its safety and tolerability in preterm infants, and infants with certain types of heart disease and lung disease. The overall results determined that nirsevimab could protect the broader infant population in a single dose.

Nirsevimab is a single dose long-acting antibody that is designed to offer direct protection to newborns and infants against RSV and LRTI. The FDA will decide if nirsevimab is approved in the latter half of 2023, and if approved, it will be commercially available in the US for the 2023/2024 RSV season.

“A substantial burden of disease from RSV affects infants, families, and healthcare providers every year. Effective interventions to prevent RSV are a critical need,” Muller said.


AstraZeneca. Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months. News Release. January 5, 2023. Accessed on January 5, 2023. https://www.astrazeneca.com/media-centre/press-releases/2023/nirsevimab-us-regulatory-submission-accepted-for-the-prevention-of-rsv-lower-respiratory-tract-disease-in-infants-and-children.html

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