Atlas
Recently, the international authoritative medical journal " New England Medical Journal " published a latest research article showing that Nirsevimab, a monoclonal antibody of respiratory syncytial virus (RSV) jointly developed by Sanofi Pasteur and AstraZeneca and has an extended half-life, significantly reduced the number of cases of lower respiratory tract infection caused by RSV during the entire RSV epidemic season. This result reveals for the first time the broad prospects of this preventive monoclonal antibody in preventing RSV infection in infants and young children and reducing family and socio-economic burden.
Nirsevimab can reduce the rate of lower respiratory tract infection caused by RSV and hospitalization rate
study results show that within 150 days of Nirsevimab injection, the rate of lower respiratory tract infection caused by RSV in the trial group decreased by 70.1% compared with the control group (95% CI: 52.3%-81.2%). Meanwhile, within 150 days of Nirsevimab injection, the hospitalization rate of lower respiratory tract infection caused by RSV in the trial group decreased by 78.4% compared with the control group (95% CI: 51.9%-90.3%). Furthermore, Nirsevimab's safety was similar to placebo saline and no hypersensitivity was observed.
study author, professor of pediatrics, professor of microbiology and immunology, and director of the Global Maternal and Infant and Pediatric Health Program, Joseph, professor of mother and child and pediatric health program at the State Medical University of New York "Nirsevimab's data is exciting because it only takes one injection throughout the RSV epidemic season to protect babies from infection. This innovative approach has great potential to reduce the number of outpatient, emergency and hospitalizations and significantly reduce the burden on the medical system."
RSV is the primary pathogen of hospitalization for acute lower respiratory tract infection in infants and young children
RSV is an infectious virus that causes respiratory infections, the primary pathogen of acute lower respiratory tract infections in infants and young children (mainly bronchiolitis and pneumonia ), and the primary factor in hospitalization for lower respiratory tract infections in infants and young children. Globally, 99% of deaths under the age of 5 are in developing countries due to RSV. Worldwide, almost all children have been infected with RSV before the age of 2, and 80% of infants and young children hospitalized due to RSV infection are originally healthy children. According to research estimates, in 2015, more than 33 million new cases of acute lower respiratory tract infections related to RSV were hospitalized, resulting in about 3.2 million people being hospitalized and 59,600 deaths in hospitals in children under 5 years old.4. About 45% of hospitalization and hospital deaths caused by acute lower respiratory tract infection caused by respiratory syncytial virus were infants under 6 months old.
Directional Diseases Director of the National Center for Clinical Medical Research on Respiratory Diseases and Professor Shen Kunling of Beijing Children's Hospital Affiliated to Capital Medical University said: "RSV infection is the primary factor in hospitalization and even death caused by lower respiratory tract infections such as pneumonia or bronchioles, and it seriously endangers the health of children. Some children with severe conditions may also experience symptoms such as apnea and need to use a ventilator in the ICU, which brings great pain to children and families."
China urgently needs effective drugs to reduce the burden of RSV disease
At present, there is no effective drug for preventing and treating RSV-related diseases in the Chinese market. Due to the lack of effective antiviral drugs and vaccines, treatment methods are still mainly focused on isolating care and relieving symptoms. In addition, there is a lack of large-scale RSV disease surveillance in China, and the RSV diagnosis rate is also relatively low, which all leads to a serious lack of awareness of RSV.
"It is encouraging that trial data show that through injection of Nirsevimab, serious complications caused by RSV in high-risk infants and healthy premature babies are significantly reduced." John Shiver, senior vice president of global R&D at Sanofi Pasteur, said, "80% of infants and young children hospitalized for RSV are healthy before infection and have no complications before infection. But there are currently no approved preventive measures to protect their health."
Currently, based on the evaluation of the results of the Phase II Phase B clinical trial, Nirsevimab has been recognized as a "breakthrough therapy" by the U.S. Food and Drug Administration and has been approved to be selected as the "Prioritative Drug Program" of the European Medicines Administration. In Japan, Nirsevimab was also selected by the Japan Medical Research and Development Agency as the "Priority Development Drugs" in the "Drug Selection Research Program to Promote the Development of New Pediatric Drugs".
Shen Kunling said, "At present, there are still great unmet medical needs in the field of RSV prevention and treatment. If Nirsevimab can be finally launched, it will fill a big gap in the field of RSV infection prevention. We hope to launch relevant clinical trials in China as soon as possible to benefit all Chinese infants and young children."
It is reported that Sanofi Pasteur is working with all parties to jointly promote the launch of Nirsevimab, a preventive monoclonal antibody for respiratory syncytial virus, in China, to protect hundreds of millions of Chinese children and families from RSV.
Editor in charge: Wang Kunshuo
