In addition to influenza and common cold, respiratory syncytial virus (RSV) infection can also cause cold-like symptoms, further evolve into lower respiratory tract infection is often common in young children. In addition to increasing the risk of asthma in children, syncytial virus infection is also the primary pathogenic factor leading to infant hospitalization worldwide, and most hospitalizations occur in healthy full-term infants. In 2019, among the children under the age of 5, there were about 33 million RSV-related acute lower respiratory tract infection in cases, resulting in more than 3 million hospitalizations, and an estimated 26,300 children died in hospitals. In 2017, direct medical expenses for RSV-related (including hospitalization, outpatient and follow-up care) of . Currently, there are no prevention programs for all infants, and treatment is limited to symptoms relief.
Nandu reporter learned on the 17th that the European Medicines Agency's Human Use Pharmaceutical Products Committee (CHMP) adopted a positive opinion on the long-acting monoclonal antibody of respiratory syncytial virus, Beyfortus (nirsevimab), jointly developed by Sanofi and AstraZeneca , and recommended the approval of Beyfortus for newborns and infants, helping them prevent lower respiratory tract infections caused by their infection when the first respiratory syncytial virus epidemic season arrives. Once is approved, Beyfortus will be the first and only single dose of passive immunization preparation that can be widely used in infants, including healthy babies who are full-term or prematurely born, or babies with special health conditions.
It is reported that the monoclonal antibody has been awarded the "breakthrough therapeutic drug program" by the Drug Review Center of the China National Drug Administration (CDE), which means that the marketing process in my country will also be accelerated.
Respiratory syncytial virus infection can cause cold-like symptoms, further evolve into lower respiratory tract infections often common in young children.
It is reported that the EU professional department made this proposal to approve this proposal based on the results of the clinical trial of this monoclonal antibody. It confirms that a single dose of Beyfortus in the epidemic season of syncytial virus infection can effectively prevent lower respiratory tract infections caused by infection and require medical treatment. Once approved, Beyfortus will become the first RSV prevention method that can be widely used in newborns and infants. Jean-François Toussaint, global head of R&D at Sanofi vaccine, said, "The positive opinion recommended today is one of the most important public health achievements in the field of syncytial virus infection in decades and is expected to reduce the huge physiological and psychological burden that this type of infection brings to families and health systems. Our goal is to provide better preventive protection for all babies through a single dose, and the European Medicines Agency's Human Pharmaceutical Products Committee means we are going further away from this goal." Iskra, Executive Vice President of AstraZeneca Vaccine and Immunotherapy, Iskra, Executive Vice President of AstraZeneca Vaccine and Immunotherapy. Reic said, "The positive opinions of the European Medicines Agency's Human Use Pharmaceutical Products Committee emphasize that Beyfortus has the potential to become a landmark, first-class passive immune preparation and transform the way the entire medical community prevents syncytial virus infection in infants."
It is reported that in previous international multi-center clinical studies on the safety and effectiveness of Beyfortus, the main endpoint of the study was achieved: that is, safety, effectiveness, and can provide good immune protection for infants and young children. The relevant conclusions have been published in the world's top medical academic journal, the New England Journal of Medicine.
At present, Beyfortus has obtained accelerated development qualifications from multiple regulatory agencies around the world. These include the "breakthrough therapeutic drug program" granted by the China National Drug Administration Center for Drug Review (CDE); the breakthrough therapy certification granted by the U.S. Food and Drug Administration (FDA); the priority drug program licensed by the European Medicines Agency (EMA); the qualification certification of "breakthrough innovative drugs" granted by the UK Drug and Health Products Administration (MHRA); and the "priority development drug" in the drug selection program promoted the development of new pediatric drugs by the Japan Medical Research and Development Agency (AMED). The safety and effectiveness of Beyfortus are reviewed in accordance with the EMA's accelerated review process and have not yet been formally approved by regulators.
Interview and writing: Nandu reporter Wang Daobin Correspondent Sun Yu
