Sanofi's respiratory syncytial virus (RSV) preventive antibody injection 'Beyfortus' (ingredient: nirsevimab) has been launched in the country. With the ongoing domestic RSV outbreak, the company sees Beyfortus as a means to prevent infections in infants.
On the 6th, Sanofi Korea announced that Beyfortus has passed the Drug Committee (DC) of medical institutions, primarily general hospitals, and has entered the domestic prescription market as of the previous day. Beyfortus received approval from the Ministry of Food and Drug Safety in April of last year. It is currently available for vaccination at major hospitals nationwide.
RSV is a highly contagious virus that infects 90% of infants under 2 years old. It typically peaks in South Korea every year from October to March. Symptoms begin with a runny nose and pharyngitis, followed by coughing and wheezing 1 to 3 days later, and in severe cases, it can worsen into lower respiratory infections like pneumonia, requiring hospitalization.
Beyfortus is the first RSV preventive antibody injection developed for all infants, including healthy full-term or premature infants and those with specific underlying conditions that make them vulnerable to RSV disease. It provides a long-lasting preventive effect with a single dose. Beyfortus has also received approval for use in various countries, including the European Union (EU), the United States, China, and Japan.
Currently, there are no RSV preventive vaccines available domestically. Last December, the Ministry of Food and Drug Safety approved the RSV vaccine 'Arexvy' from the British company GlaxoSmithKline (GSK), but it is set to be released in June and is aimed at adults aged 60 and older. Vaccines targeting infants are also in development, but it is expected to take some time before they are approved in the country.
In this context, Sanofi expects that Beyfortus will play an important role in the RSV vaccines and therapeutics market. Beyfortus is available for all newborns and infants during their first RSV outbreak season.
Considering that about half of the infants hospitalized due to RSV infections are born before the outbreak season begins, Sanofi anticipates that quickly vaccinating with Beyfortus will be effective in lowering the infection rate among infants. Beyfortus can also be administered to children under 24 months who are at high risk for severe RSV disease.
Park Hee-kyung, head of Sanofi's Vaccines Division, said, "Given the current nationwide outbreak of RSV, I hope that the launch of Beyfortus will allow infants at high risk of RSV infection to benefit from prevention this season," and added, "As there has been a significant decrease in RSV-related hospitalizations abroad with Beyfortus, it is expected to also help alleviate the burden on families with infants in the country."