Nirsevimab, a single-dose respiratory syncytial virus (RSV) preventative option for newborns and infants that showed nearly 75% efficacy in clinical trials, could be available soon, according to maker AstraZeneca.
AstraZeneca, which is developing the drug in collaboration with Sanofi, announced in January that the Food and Drug Administration (FDA) accepted its Biologics License Application for nirsevimab for review and indicated it would work to expedite the review process. The target action date for the FDA’s decision is set for the third quarter of 2023. If approved, nirsevimab is expected to be available in the US for the 2023/2024 RSV season.
“This decision brings us a step closer to delivering a first-in-class preventative option for a broad infant population in the US,” says Iskra Reic, executive vice president of vaccines and immune therapies at AstraZeneca, in the 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.”
The Biologics License Application was based on results from the nirsevimab clinical development program, including the MELODY Phase 3 (primary cohort and all subjects), MEDLEY Phase 2/3 (first and second RSV season), and Phase 2b trials.
Data from the MELODY trial was published in the New England Journal of Medicine in March 2022 and demonstrated a reduction in the incidence of medically attended lower respiratory tract infections caused by RSV by 74.5% versus placebo through day 151 (a typical RSV season) with a single dose.
A long-acting monoclonal antibody, nirsevimab also demonstrated a comparable safety and tolerability profile to Synagis (palivizumab) in the MEDLEY Phase II/III trial, with occurrence of treatment-emergent adverse events or treatment-emergent serious adverse events similar between groups.
“A substantial burden of disease from RSV affects infants, families, and healthcare providers every year. Effective interventions to prevent RSV are a critical need. This year in the US, we’ve seen firsthand 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,” says William Muller, MD, PhD, associate professor of pediatrics at Northwestern University Feinberg School of Medicine and scientific director of clinical and community trials at Ann & Robert H. Lurie Children’s Hospital of Chicago, in the press release.
In November 2022, nirsevimab was granted marketing authorization in Europe to prevent RSV lower respiratory tract disease in newborns and infants during their first RSV season, under the name Beyfortus.
Currently, the only available preventative option for RSV in the US is palivizumab, which is limited to high-risk infants and provides one-month protection, requiring five injections to cover an RSV season.
