FDA will review monoclonal antibody for RSV protection in infants
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The FDA will review a biologics license application for nirsevimab for the prevention of respiratory syncytial virus in newborns and infants, according to Sanofi and AstraZeneca, which are developing the monoclonal antibody.
The companies said the FDA will work to expedite the review, with a decision expected in the third quarter of 2023.
The FDA will consider the single-dose antibody for infants entering their first RSV season and children up to age 24 months who remain vulnerable to the virus through their second season, the companies said.
A recent surge in RSV, which followed the lifting of precautions for COVID-19, has stretched hospital capacity in the United States.
Trials of nirsevimab have reported promising results against RSV. Data from multiple trials, including the phase 3 MELODY trial, showed consistent protection of approximately 80% against medically attended RSV with a single dose.
Thomas Triomphe, MSc, executive vice president of vaccines at Sanofi, called the FDA’s review “a landmark” considering the surge in pediatric hospitalizations due to RSV.
“[This] brings us one step closer to offering the first and only broadly protective option against RSV disease designed for all infants,” Triomphe said in a press release. “Given the unprecedented number of otherwise healthy infants who have been hospitalized with RSV this year in the U.S. and the recurrent pattern of RSV epidemics year after year, it is our intention to make nirsevimab available, if approved in time, for the 2023/2024 season to help alleviate the burden of RSV on families and the health care system.”
William J. Muller, MD, PhD, associate professor of pediatrics at Northwestern University Feinberg School of Medicine and scientific director of clinical and community trials at Lurie Children’s Hospital of Chicago, was also quoted in the release.
“A substantial burden of disease from RSV affects infants, families, and health care providers every year,” Muller said. “Effective interventions to prevent RSV are a critical need. This year in the U.S., we’ve seen first-hand how frightening the impact of this respiratory disease is on our patients and how stressful it is on the health care system, highlighting the urgency of addressing this problem.”