Sanofi Korea launches RSV preventive antibody Beyfortus

Sanofi Korea said it officially launched of Beyfortus (ingredient: nirsevimab) in Korea, marking the availability of the first respiratory syncytial virus (RSV) preventive antibody injection for all newborns and infants in the country.

Beyfortus received approval from the Ministry of Food and Drug Safety in April 2024 and has since been incorporated into the prescription system at major hospitals nationwide. As of Wednesday, the drug has officially entered the Korean market and is now available at major hospitals and clinics across the country.

RSV is a highly contagious virus, affecting approximately 90 percent of children under the age of two. While RSV infections may present as mild cold-like symptoms, they can escalate into bronchiolitis or pneumonia, often requiring hospitalization.

RSV is recognized as the most common viral cause of bronchiolitis and pediatric pneumonia, posing a greater risk to infants with narrower airways. As no specific treatments exist for RSV, prevention has been a growing priority in pediatric healthcare.

In their first RSV season, 78 percent of infants hospitalized due to RSV-related lower respiratory tract infections were full-term and previously healthy. Until now, there have been no RSV prevention options available for this group, leaving a significant unmet medical need. The introduction of Beyfortus is expected to bridge this gap.

Beyfortus is indicated for administration to all newborns and infants entering their first RSV season. Given that approximately 50 percent of RSV-related hospitalizations occur in infants born just before the RSV season begins, early administration of Beyfortus is expected to reduce hospitalization rates.

Also, the drug can also be administered to children under 24 months at high risk of severe RSV disease during their second RSV season, expanding its preventive coverage.

“We are delighted to introduce Beyfortu in Korea, making RSV prevention available to all full-term newborns and infants,” Sanofi Korea Vaccines Head Christine Park said. “With RSV spreading nationwide, we expect that Beyfortus will provide immediate benefits in protecting high-risk infants this season.”

International data has already demonstrated a significant reduction in RSV-related hospitalizations with Beyfortus use, and the company anticipates a similar impact in Korea, Park added.