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The global phase III clinical trial of the prophylactic monoclonal antibody: Nirsevimab proved to protect healthy infants from respiratory syncytial virus.
In January 2021, Nirsevimab obtained the “Breakthrough Innovative Drug” qualification from the Medicines and Healthcare Products Administration (MHRA) of the United Kingdom.
In February 2019, Nirsevimab was approved by the U.S. Food and Drug Administration (FDA) as a “breakthrough therapy” for the prevention of lower respiratory tract infections caused by respiratory syncytial virus, and was approved to be selected by the European Medicines Agency (EMA). Priority Drug Program”.
In Japan, nirsevimab has also been selected by the Japan Agency for Medical Research and Development (AMED) as a “priority drug for development” in the “Drug Selection Research Program to Promote the Development of New Pediatric Drugs”.
(Paris, April 26, 2021) – Nirsevimab’s phase III MELODY clinical trial announced positive key results: nirsevimab reduced the outpatient and hospitalizations of lower respiratory tract infections caused by respiratory syncytial virus in healthy infants.
Respiratory syncytial virus is the leading cause of lower respiratory tract infections in all infants, and it is also the leading cause of hospitalization for infants with lower respiratory tract infections 1-5.
Nirsevimab reached the primary endpoint: In the entire typical respiratory syncytial virus epidemic season, compared with the placebo group, lower respiratory tract infections caused by respiratory syncytial virus in healthy premature infants and full-term infants in the nirsevimab group showed statistically significant Absolutely reduced.
There were no significant clinical differences in safety results between the nirsevimab group and the placebo group. In this trial, the overall safety of nirsevimab was consistent with previously reported results.
William Muller, Associate Professor of Pediatrics at Northwestern University Feinberg School of Medicine, Director of Clinical and Community Trials at Ann & Robert H. Lurie Children’s Hospital in Chicago, Illinois, USA, and lead investigator of the MELODY Phase III clinical trial, William Muller, said: “Respiratory syncytial virus is The main causes of pneumonia and bronchiolitis in the first year after birth are infants, but there are currently no routine preventive measures applicable to all infants.
These exciting test data show that nirsevimab can not only provide protection for the majority of infants throughout the respiratory syncytial virus epidemic season, but also can achieve this goal through single-dose therapy, which is expected to change the prospect of disease prevention. “
Nirsevimab, jointly developed by Sanofi Pasteur and AstraZeneca, is the world’s first long-acting prophylactic monoclonal antibody. It aims to protect all infants who have experienced respiratory syncytial virus epidemics for the first time. These infants are severely ill. The risk of respiratory syncytial virus-related diseases is the highest1,6,7.
Nirsevimab adopts a passive immune mechanism. Infants can quickly gain immunity to respiratory syncytial virus with only one intramuscular injection, thereby obtaining protection throughout the respiratory syncytial virus epidemic season.
Jean-François Toussaint, head of global research and development at Sanofi Pasteur, said: “Respiratory syncytial virus is the main cause of hospitalization for all babies. In fact, most hospitalizations occur in healthy babies born at full-term. Obviously, all babies are Need to be protected from respiratory syncytial virus, and we hope that nirsevimab will become an important supplement to routine immunization programs.”
Mene Pangalos, Executive Vice President of Research and Development of AstraZeneca Biopharmaceuticals, said: “These breakthrough results mark a major scientific advancement in our protection against respiratory syncytial virus for all infants.
Almost all babies will be infected with the virus before the age of two, which causes nearly 30 million cases of acute lower respiratory infections each year.
Nirsevimab has the potential to become the first respiratory syncytial virus immunization method for all infants, resulting in major public health benefits. These data bring us one step closer to providing nirsevimab to infants around the world. “
At present, clinical studies of the preventive monoclonal antibody nirsevimab have been carried out simultaneously in more than 30 countries around the world. Phase III clinical studies for healthy Chinese babies are also about to start.
It is reported that Sanofi Pasteur and its partner AstraZeneca are working with all parties to jointly promote the listing of nirsevimab in China and protect tens of millions of Chinese babies from respiratory syncytial virus.
About the Phase III MELODY clinical trial
This phase III study is a randomized, placebo-controlled clinical trial for healthy infants entering the first RSV epidemic season. It aims to evaluate nirsevimab-controlled placebo due to lower respiratory tract infection (LRTI) caused by RSV within 150 days after injection. The incidence of doctor visits and RSV infection need to be confirmed by reverse transcriptase polymerase chain reaction (RT-PCR) testing.
Healthy preterm infants and full-term infants with a gestational age of 35 weeks and 0 days or older are randomized (2:1) to receive a single dose of nirsevimab 50 mg (for infants weighing less than 5 kg) or 100 mg (for infants weighing ≥ 5 kg) or comfort Agent. Between July 2019 and February 2021, approximately 1,500 infants were treated with nirsevimab or placebo at the beginning of the RSV season.
The research was carried out in 21 countries. The study will add 1,500 infants to clinical trials in the northern and southern hemispheres to complete safety assessments.
In July last year, the detailed results of the positive phase 2b trial of nirsevimab were published in the New England Journal of Medicine. The results showed that healthy premature infants had lower respiratory tract infections (mainly bronchiolitis and pneumonia) caused by respiratory syncytial virus (RSV). Both the hospitalization rate and the hospitalization rate dropped significantly.
About Respiratory Syncytial Virus
Respiratory syncytial virus is a highly contagious virus that causes respiratory tract infections. It is the most common pathogen of bronchiolitis and pneumonia. It has caused millions of infants and children under the age of 1 to be hospitalized worldwide due to respiratory syncytial virus infection. Treatment 4.
According to research estimates, in 2015, there were more than 33 million new cases of lower respiratory tract infections related to respiratory syncytial virus in the world, resulting in more than 3 million hospitalizations and about 60,000 deaths in hospitals for children under 5 years of age.
About 67%~79% of infants and young children hospitalized due to respiratory syncytial virus infection were originally healthy children7,8. In addition, outpatient, emergency and hospitalization caused by lower respiratory tract infections have increased the burden on the medical system.
Nirsevimab is a prophylactic monoclonal antibody with prolonged half-life. It is used to prevent lower respiratory tract infection-related diseases caused by respiratory syncytial virus. It is suitable for all infants and young children who experience the epidemic season of respiratory syncytial virus for the first time, as well as for the first time and Children with chronic lung disease or children with congenital heart disease who experienced the respiratory syncytial virus epidemic season for the second time.
Nirsevimab uses a passive immune mechanism to help prevent respiratory syncytial virus infection-related diseases by directly administering antibodies to infants and young children. Unlike the active immune mechanism that needs to activate the human immune system to resist viral infections, the passive immune mechanism can provide rapid protection.
(source:internet, reference only)