1st RSV preventive inj 'Beyfortus' can be prescribed

at general hospitals in KOR

Has landed at major medical centers, including Seoul National University Hospital·Korea University Hospitals

Beyfortus, based on a Phase 3 clinical trial, demonstrated a 74% reduction in lower respiratory infection caused by RSV

Product photo of Beyfortus

The first injectable antibody drug approved in South Korea to prevent respiratory syncytial virus (RSV), 'Beyfortus,' is now available for prescription at general hospitals.

 

According to industry sources, Sanofi Korea's Beyfortus (nirsevimab) has passed the drug committees (DC) of medical centers, including Seoul National University Hospital, Cha University Gangnam Medical Center, Korea University Anam Hospital, Korea University Ansan Hospital, Cha University Bundang Medical Center, and Pusan National University Yangsan Hospital.

 

Beyfortus was approved by the Ministry of Food and Drug Safety (MFDS) in May as an injectable antibody to prevent RSV.

 

It can be administered to all newborns and infants during their first RSV season.

 

Beyfortus can also be given to infants under 24 months who are at high risk for severe RSV disease during their second RSV season.

 

The Phase 3 MELODY study, which was the basis of Beyfortus approval, showed that the lower respiratory infection by RSV was reduced by 74.5% in the Beyfortus-treated group.

 

This study evaluated the effectiveness of Beyfortus in 3012 infants born after 35 weeks during their first RSV season.

 

The effectiveness in preventing RSV infections requiring medical attention was assessed until 150 days after the Beyfortus administration.

 

Based on the Beyfortus real-world evidence demonstrated in the interim results from the national immunization program in Galicia, Spain, infants six months or younger who were administered Beyfortus had an 82% reduction in hospitalization due to RSC compared to non-administered infants.

 

"Individuals of all ages can be contracted with RSV, but 90% of infants under 2 years old become infected.

 

When infected, a mild cold symptom can advance to lung infections, possibly leading to hospitalization," Ki Wook Yun, Professor of Seoul National University College of Medicine, explained.

 

"When infants without completely developed bronchial tubes contract RSV, symptoms can be worse.

 

It could result in socioeconomic loss in addition to affecting family members." Yun added, "Since taking care of one's hygiene was the only RSV prevention available, there were unmet needs for RSV prevention.

 

With the availability of injectable antibody drug, active RSV prevention is expected to be possible."