2024-02-27 05:54:31
Roche Korea (CEO Nick Horridge) announced on February 27 that its influenza treatment drug, Xofluza (ingredient name: baloxavirmarboxil), was used for the treatment and exposure of influenza type A or B virus infection in children over 1 year of age. It was announced that a new suspension formulation has been launched as a preventative treatment.
In October of last year, Xofluza received expanded approval from the Ministry of Food and Drug Safety for the treatment of influenza type A or B virus infection and post-exposure prophylaxis in children over 1 year of age. It is easier for children to take than existing tablets (pills). A suspension formulation, which is a granule that dissolves in water, also received approval for expanded indications. Accordingly, Xofluza can now be used for influenza treatment and post-exposure prophylaxis with just one dose in all age groups, including children, adolescents, and adults over 1 year of age.
Influenza is an acute respiratory disease caused by a virus, which can cause complications in major organs such as pneumonia and respiratory and nervous system complications, leading to death in severe cases. In particular, it causes socioeconomic losses, including increased morbidity and mortality in high-risk groups such as infants, the elderly, people with chronic diseases, and pregnant women. Among infants and young children, the risk of complications is high in children under 5 years of age, and caution is required in children over 5 years of age due to the high risk of spreading the flu to family members.
Xofluza is a new antiviral drug developed in about 20 years. It inhibits the polymerase acidic endonuclease protein, which is essential for influenza virus replication, and prevents the progression of virus replication from the initial stage. With just one dose, it can quickly relieve influenza symptoms and shorten the time for the influenza virus to be detected, preventing further transmission. Consistent effects were confirmed even in high-risk groups such as the elderly and those with chronic diseases.
The expansion of indications in October last year was made based on the phase 3 clinical studies miniSTONE-2 and BLOCKSTONE. As a result of the study, Xofluza shortened the time until the detection of influenza infectious virus stopped by more than 2 days compared to oseltamivir, and no serious adverse reactions occurred after Xofluza administration. Additionally, it showed a significant preventive effect by reducing the risk of developing influenza after exposure to a family member infected with Xoflu by 86% compared to the placebo group.
Professor Ji-Man Kang of the Department of Pediatrics at Yonsei University Severance Hospital said, “As seen in the recent flu pandemic, influenza spreads through daycare centers, schools, and homes, increasing the socioeconomic burden, and the younger the patient, the more severe the symptoms and the risk of serious complications. “A new treatment that is effective and can increase medication compliance was needed,” he said.
“We are pleased to be able to provide the benefits of Xofluza in a more convenient formulation to children who are at high risk for influenza,” said Shin Soo-hee, Healthcare Innovation Cluster Lead, who is in charge of the Roche Korea division. “With this expansion of Xofluza indications, the number has reached 1 in Korea. “It has become possible to treat and prevent influenza with just one dose for children over the age of 10, teenagers, and adults,” he said.
Meanwhile, Xofluza was approved as a treatment for influenza type A or B virus infection in adults and adolescents aged 12 years or older in 2019, and for post-exposure prevention of influenza type A or B virus infection in adults and adolescents aged 12 years or older in 2021. The indications for therapy have been expanded.
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