Baloxavir Marboxil Approved for Pediatric Use in China, Offering a Novel Mechanism-Based Treatment Option for Influenza

Reporters learned on the 25th that the innovative influenza drug Xofluza® (Chinese generic name: Baloxavir Marboxil) has been officially approved by the China National Medical Products Administration for the treatment of otherwise healthy adults and children aged 5 years and above with uncomplicated influenza A or B, or for adults and children aged 12 years and above who are at high risk of influenza-related complications.

 

It is reported that the approval of the pediatric indication for baloxavir marboxil has provided a new treatment option for children with influenza.

 

Baloxavir marboxil is an anti-influenza drug with an innovative mechanism of action. It requires only a single oral dose to stop viral shedding within about 24 hours, shorten the contagious period, and quickly alleviate flu symptoms such as fever and body aches. In April 2021, baloxavir marboxil was approved in China for treating patients aged 12 years and older with uncomplicated influenza A or B. Just eight months after its approval, baloxavir marboxil was included in the National Reimbursement Drug List (NRDL).

 

Influenza is a serious infectious disease that can have severe consequences for the public.HealthPose a significant threat.ChildrenChildren are at high risk for influenza, with an annual incidence rate of about 20%-30%. During peak flu seasons, the infection rate can reach as high as 50%, and children aged 5-9 have the highest infection rates. Data from China’s surveillance on influenza-like illness and virological monitoring show that outpatient visits for flu-like illness are heaviest among children under 15, significantly higher than in adults. The majority of flu-related hospitalizations in China are for children under 15, some of whom may progress to severe cases. The main causes of death in pediatric flu cases are respiratory complications and flu-associated encephalopathy or encephalitis.

 

According to reports, influenza virus infection is mainly characterized by clinical manifestations such as fever, headache, and myalgia. Children often experience rapid onset of the disease, with higher fevers than adults. If influenza is confirmed or highly suspected, antiviral treatment within 48 hours is most effective. The innovative mechanism of action of Baloxavir can directly block the replication of the influenza virus.

 

Ghosen, President of a related multinational pharmaceutical company in China, said: "It is now the peak season for spring influenza in China. We are delighted to hear that the countryMedicineThe Supervision and Administration Bureau has quickly approved the pediatric indication for Xofluza® at this time. We hope to work together with all sectors of society to rapidly improve the accessibility of Xofluza®, protecting every family and every child."