AstraZeneca-Sanofi Nirsevimab unanimously recommended by USFDA Advisory Committee for prevention of RSV in infants
London: The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) has voted unanimously 21 to 0 that AstraZeneca and Sanofi’s nirsevimab has a favourable benefit risk profile for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. The Committee also voted 19 to 2 in support of nirsevimab’s favourable benefit risk profile for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Nirsevimab has the potential to protect the broad infant population through its first RSV season, including those born healthy at term or preterm, or with specific health conditions that make them vulnerable to RSV disease. The single dose can be flexibly administered at the beginning of the RSV season or at birth for newborns born during the RSV season.
The FDA accepted the Biologics License Application (BLA) for nirsevimab in 2022 and the agency has indicated it will work to expedite its review. The Prescription Drug User Fee Act date is in the third quarter of 2023. If approved by that time, nirsevimab will be available in the US ahead of the 2023-2024 RSV season.
Dr 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 said, “RSV remains the most common cause of bronchiolitis and pneumonia in infants, and the inability to predict which infants will develop severe RSV disease leads to uncertainty for new parents and for physicians. The innovation of nirsevimab as a long-acting antibody that can be conveniently administered to a broad infant population with a single-dose at the time protection is most needed is a significant public health advancement that could have far-reaching impact on the well-being of our families and healthcare systems in the US.”
Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said, “We are delighted that the Antimicrobial Drugs Advisory Committee has unanimously recognised the favourable benefit risk profile of nirsevimab as the first preventative option against RSV for a broad infant population. Nirsevimab builds on AstraZeneca’s strong science, leadership in RSV and commitment to addressing the needs of the most vulnerable. We look forward to continuing to work with the FDA to complete their expedited review, and we hope to see nirsevimab available as soon as possible given the significant burden of RSV in infants.”
Thomas Triomphe, Executive Vice President, Vaccines, Sanofi, said, “Most babies hospitalised with RSV are born at term and healthy, which is why interventions specifically designed to protect all infants are likely to result in the greatest impact. We are encouraged by the Advisory Committee’s positive vote based on the compelling clinical development program supporting nirsevimab and its breakthrough potential to reduce the magnitude of annual RSV burden.”
RSV is a very contagious virus that can lead to serious respiratory illness, according to the Centers for Disease Control and Prevention (CDC). In the US, RSV is the leading cause of hospitalisation for babies under one. About 75% of infants hospitalised for RSV in the US were born at term with no underlying conditions.
The AMDAC based its recommendation on the nirsevimab clinical development programme spanning three pivotal late-stage clinical trials, including results from the MELODY Phase III trial recently published in the New England Journal of Medicine. Across all clinical endpoints, a single dose of nirsevimab demonstrated sustained and consistent reduction in RSV LRTD requiring medical care vs placebo through the entire RSV season. Nirsevimab was generally well tolerated with a favourable safety profile that was consistent across all clinical trials. The overall rates of adverse events were comparable between nirsevimab and placebo and the majority of adverse events were mild or moderate in severity.
