Respiratory syncytial virus (RSV) innovative drug! AstraZeneca/Sanofinirsevimab: Single injection for up to 5 months of long-lasting protection!

!--webeditor: "page title" -- August 01, 2020 /PRNewswire/ -- Recently, the New England Journal of Medicine (NEJM), an international authoritative medical journal, published online positive data on a phase IIb clinical trial of Sanofi and AstraZeneca's monoantivirus (RSV) monoantivirus (Snirsimevab).
results showed that in the RSV epidemic season, in healthy premature infants, nirsevimab single-dose intramuscular injection significantly reduced the treatment and hospitalization rates of lower respiratory tract infections (RSV-LRTI) caused by RSV compared to placebos.
note, the trial has for the first time confirmed that a single-dose monoclonal antibody (mAb) can significantly reduce the attendance and hospitalization of RSV-LRTI (including capillary bronchitis and pneumonia) in infants throughout the RSV epidemic season.
nirsevimab is an RSV monoclonal antibody with an extended half-life (an average of 59.3 days), developed by AstraZeneca and Sanofi as a passive immunotherapy that has the potential to provide immunity directly to infants and immediate protection against RSV.
nirsevimab is the first potential infant passive immunotherapy that has been shown to provide continuous protective effectthroughy throughout the RSV epidemic season.
February 2019, the FDA granted the Breakthrough Drug (BTD) of the nirsevimab for RSV-induced LRTI prevention, and the European Medicines Agency (EMA) granted priority drug eligibility (PRIME) for the same indication.
the IIb trial was an interventionist, randomized, double-blind trial that evaluated the safety and effectiveness of nirsevimab in healthy preterm infant populations.
participants were healthy premature babies aged 29-35 weeks.
from November 2016 to December 2017, at the beginning of the RSV epidemic season, 1,453 infants were randomly assigned at a 2:1 ratio and received a 50 mg dose of nirsevab (n-969) or a placebo (n?484). the main endpoint of
is the incidence of RSV-LRTI receiving medical care within 150 days of injection.
medical care (Medically-reded) refers to any RSV-LRTI case referred to by a healthcare provider.
secondary efficacy endpoint is the incidence of hospitalization for RSV-LRTI within 150 days of injection.
the trial was conducted by AstraZeneca at 164 clinical centers in 23 countries around the world.
results showed a statistically significant 70.1% (95% CI: 52.3%-81.2%) in rsv-LRTI in the nirsevimab group, compared to the placebo group, within 150 days of administration.
secondary efficacy endpoint: In the 150 days after administration, the hospitalization rate caused by RSV-LRTI in the nirsevimab group decreased by a relative 78.4% (95% CI: 51.9%-90.3%).
study, the safety of nirsevimab was similar to that of a placebo, and no significant hypersensitivity response was observed.
11.2 percent of the subjects in the
nirsevimab group and 16.9 percent of the subjects in the placebo group had serious adverse reactions, none of which were considered to be related to nirsevimab. "
The nirsevimab data highlight the potential of this innovative treatment to protect infants from RSV infection with just one injection throughout the RSV epidemic season," said study author Dr. Joseph Domachowske, a professor of pediatrics and immunology at the University of New York's Upper State University medical school and a professor of microbiology and immunology.
nirsevimab has the potential to reduce visits, emergencies and hospitalizations, which are significant burdens on the health system. "Every year, RSV leads to more than 3 million hospitalizations worldwide and causes a large number of emergency departments for children under 5 years of age," said Mene Pangalos, executive vice president of AstraZeneca Biopharmaceutical research and development at
.
nirsevimab is an innovative monoclonal antibody with the potential to protect a wide range of infant populations.
90 per cent of infant populations are infected with the virus before the age of 2.
"respiratory syncytial virus (RSV) is a common infectious virus that infects the respiratory tract and is the primary pathogen of acute lower respiratory tract infections (LRTI, mainly capillary bronchitis and pneumonia) in infants and young children.
data show that almost all infants and young children before the age of 2 have had at least one RSV infection, and infants under 6 months of age are the main affected population.
RSV is highly contagious and can be transmitted from person to person through droplets or contact.
RSV popular season is 5 months from autumn to spring next year.
current anti-RSV antibody Synagis (palivizumab) is limited to high-risk infants and provides only one month of protection, requiring five injections to cover a typical RSV epidemic season.
nirsevimab is an RSV monotagonism with extended half-life and has been developed as a passive immunotherapy to prevent LRTI caused by RSV.
the product was developed to be used in a wider range of infant populations than current standards of care, including: infant populations that are experiencing the first RSV epidemic season, and infants with congenital heart disease or chronic lung disease who are entering the first and second RSV epidemic seasons.
nirsevimab is a passive immunotherapy that provides antibodies directly to infants to help prevent RSV;
passive immunity provides immediate protection, while active immunity takes weeks to have a protective effect.
March 2017, AstraZeneca and Sanofi reached an agreement to develop and commercialize nirsevimab.
under the terms of the agreement, AstraZeneca will lead all development activities and preliminary regulatory approvals and retain production activities, and Sanofi will lead commercialization activities.
!--/ewebeditor:!--webeditor:!--." -- In July 2019, AstraZeneca launched Key Phase III and Phase II/III trials to assess the safety and effectiveness of nirsevabim in preventing RSV-induced LRTi in full-term, healthy, advanced premature and high-risk infants.
the trial was conducted at more than 350 locations in the United States, Canada, Europe, Asia and the southern hemisphere.
() Original source: Nirsevimab reduced sync syncytial virus infection sydd yn sinterm pre-infants in Phase IIb trial !--/ewebeditor: page.