The U.S. Food and Drug Administration (FDA) has granted approval for a new drug, Beyfortus (nirsevimab-alip), designed to prevent respiratory syncytial virus (RSV) in infants and toddlers. This significant milestone comes in large part due to clinical trials conducted at SUNY Upstate Medical University, highlighting a breakthrough in the battle against RSV, the leading cause of hospitalization for children in the United States. 

The RSV treatment Dr. Joseph Domachowske helped developed for infant respiratory syncytial virus (RSV) at SUNY Upstate just received FDA approval.

Joseph Domachowske, MD, a pediatric infectious disease specialist and Professor of Pediatrics at SUNY Upstate Medical University, played a central role in the clinical trial that served as the foundation for this groundbreaking treatment. He and his team enrolled the first 3 infants in the world in January 2015. Since then, phase after phase of trials in different groups of newborns continued to prove safe for babies. “It gives me chills just thinking about seeing that data come in. In every group of babies that's been studied, it works,” Says Domachowske. “It's at least 80% effective at preventing RSV hospitalizations or medically attended visits for pneumonia in every newborn group studied.” He explains that the data on safety has also been phenomenal. “We've been studying it for seven years; more than 6000 infants have gotten it. It's very safe. It's as safe as giving a saltwater placebo injection. There's no indication that there are any reactions of concern.” 

RSV has long been a significant concern for pediatricians and parents, often resulting in severe illness and hospitalizations among young children. With this FDA approval, healthcare providers now have a powerful tool to proactively shield vulnerable infants and toddlers from RSV, potentially averting hospitalizations and minimizing the long-term consequences associated with the virus. Domachowske is hopeful about the impact Beyfortus will have on babies’ health. “If this new monoclonal antibody is administered to all infants entering their first RSV season as intended, major shifts in the landscape of infant RSV will become evident quickly.” 

Moving forward, the approval of this novel drug emphasizes the crucial role of collaborative research in advancing pediatric medicine. The tireless efforts of Dr. Domachowske and his team at SUNY Upstate Medical University highlight the significance of academic institutions in driving scientific innovation and improving healthcare outcomes for children. 

You can read more about Dr. Domachowske's efforts to create Beyfortus here.

See the full announcement from the FDA here.