FDA Accepts BLA for RSV Prevention in Infants
Nirsevimab is a single-dose, long-acting antibody to protect infants from respiratory syncytial virus (RSV) lower respiratory tract infections. The FDA action date is in the third quarter of 2023.
The FDA has accepted a biologics license application (BLA) for nirsevimab to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and children up to 24 months of age. Nirsevimab is being developed and commercialized by AstraZeneca in collaboration with Sanofi. It is a single-dose, long-acting antibody designed to protect infants entering or during their first RSV season and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
The Prescription Drug User Fee Act date is in the third quarter of 2023. If approved at that time, nirsevimab will be available in the United States for the 2023/2024 RSV season.
William J. Muller, M.D., Ph.D.
“Effective interventions to prevent RSV are a critical need,” William J. Muller, M.D., Ph.D., associate professor, pediatrics, Northwestern University Feinberg School of Medicine, said in a press release. Muller is also scientific director, Clinical and Community Trials, Ann & Robert H. Lurie Children’s Hospital of Chicago. “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.”
The BLA was based on results MELODY clinical trial program. Data from the MELODY phase 3 trial were 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% compared with placebo through day 151. Nirsevimab also demonstrated a comparable safety and tolerability profile to Sobi’s Synagis (palivizumab), a monoclonal antibody also used to prevent RSV in infants, in the MEDLEY phase 2/3 trial, with occurrence of treatment emergent adverse events or treatment emergent serious adverse events similar between groups.
In November 2022, nirsevimab was granted marketing authorization in the European Union for the prevention of RSV lower respiratory tract disease in newborns and infants, under the name Beyfortus.
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
Remote Care Advancement for Heart Failure, COPD and Diabetes Patients
February 24th 2021In this week's episode of Tuning In to the C-Suite podcast, MHE's Briana Contreras spoke with Dr. Rob Kowal, chief medical officer of the Cardiac Rhythm and Heart Failure division at Medtronic. The two discussed how remote monitoring and IoT is changing healthcare and how remote technology is also gaining a wide-spread adoption to monitor patients at home who have chronic conditions like heart failure, chronic obstructive pulmonary disease and diabetes.
Listen
