Nirsevimab Phase IIb Trial Demonstrates Significant Reduction in RSV-Related Medical Visits and Hospitalizations in Infants

PARIS, July 30, 2020 /PRNewswire/ -- A latest research article published in The New England Journal of Medicine, an internationally authoritative medical journal, demonstrates that Nirsevimab, a long-acting monoclonal antibody against respiratory syncytial virus (RSV) jointly developed by Sanofi Pasteur and AstraZeneca, significantly reduced the number of medically attended lower respiratory tract infections caused by RSV throughout the entire RSV season in Phase 2b clinical trials. These results reveal for the first time the broad potential of this preventive monoclonal antibody in protecting infants and young children from RSV infection and alleviating the familial and socioeconomic burden.

Nirsevimab Significantly Reduces Healthcare Visits and Hospitalization Rates for Lower Respiratory Tract Infections Caused by RSV

The study results showed that within 150 days after Nirsevimab injection, the rate of outpatient visits for RSV-induced lower respiratory tract infections in the trial group decreased by 70.1% compared to the control group (95% CI: 52.3%-81.2%). Meanwhile, within 150 days after Nirsevimab injection, the hospitalization rate for RSV-induced lower respiratory tract infections in the trial group decreased by 78.4% compared to the control group (95% CI: 51.9%-90.3%). In addition, the safety profile of Nirsevimab was similar to that of placebo saline, and no hypersensitivity reactions were observed.^[1]。

Dr. Joseph Domachowske, a study author, Professor of Pediatrics and Professor of Microbiology and Immunology at SUNY Upstate Medical University, and Director of the Global Maternal and Pediatric Health Program, stated, “The data on nirsevimab are encouraging, as a single injection throughout the RSV season can protect infants from infection. This innovative approach holds significant potential to reduce outpatient visits, emergency department visits, and hospitalizations, thereby substantially alleviating the burden on healthcare systems.”

RSV is the leading pathogen causing hospitalization for acute lower respiratory tract infections in infants and young children.

RSV is a contagious virus that causes respiratory infections.^[4], is the leading pathogen causing acute lower respiratory tract infections (primarily bronchiolitis and pneumonia) in infants and young children^[5]、[6], is also the leading cause of hospitalization for lower respiratory tract infections in infants and young children^[7]. Globally, 99% of RSV-related deaths in children under five occur in developing countries^[8]. Worldwide, nearly all children are infected with RSV before the age of 2.^[9], and 80% of infants and young children hospitalized due to RSV infection were previously healthy.^[10]. According to research estimates, in 2015 there were more than 33 million new cases of RSV-associated acute lower respiratory infections worldwide, resulting in approximately 3.2 million hospitalizations and 59,600 in-hospital deaths among children under 5 years of age.^[4], approximately 45% of hospitalizations and in-hospital deaths due to acute lower respiratory infections caused by respiratory syncytial virus occur in infants under 6 months of age^[4]。

Professor Shen Kunling, Director of the National Clinical Research Center for Respiratory Diseases and affiliated with Beijing Children’s Hospital, Capital Medical University, stated, “RSV infection is the leading cause of hospitalization and even death in infants and young children due to lower respiratory tract infections such as pneumonia or bronchiolitis, posing a serious threat to children’s health. Some severely affected children may experience symptoms such as apnea, requiring mechanical ventilation in the ICU, which causes significant suffering for both the children and their families.”

China is in urgent need of effective drugs to alleviateRSVDisease Burden

China is one of the countries with the highest number of RSV infection cases globally, and together with Pakistan, India, Nigeria, and Indonesia, it accounts for nearly half of the global disease burden of acute lower respiratory infections caused by RSV.^[11]。

Currently, there are no effective drugs approved for market in China for the prevention and treatment of RSV-related diseases. Due to the current lack of effective antiviral medications and vaccines, treatment primarily focuses on isolation care and symptom relief. Furthermore, the absence of large-scale RSV disease surveillance in China, coupled with low diagnostic rates, has resulted in a significant lack of awareness regarding RSV.

Nirsevimab Poised to Change the Status Quo

“It is encouraging that trial data show a significant reduction in severe RSV-related complications among high-risk infants and healthy preterm infants following Nirsevimab injection,” said John Shiver, Senior Vice President of Global Research and Development at Sanofi Pasteur. “Eighty percent of infants hospitalized due to RSV infection were previously healthy and had no prior complications, yet there are currently no approved preventive measures to protect their health.”

Currently, based on the evaluation of the Phase 2b clinical trial results, Nirsevimab has received “Breakthrough Therapy” designation from the U.S. Food and Drug Administration (FDA) and has been accepted into the European Medicines Agency’s (EMA) “Priority Medicines” (PRIME) scheme. In Japan, Nirsevimab has also been selected as a “Priority Development Drug” under the “Drug Selection Research Program for Promoting Pediatric New Drug Development” by the Japan Agency for Medical Research and Development (AMED).

Professor Shen Kunling stated, “Currently, there is still a significant unmet medical need in the prevention and treatment of RSV. If nirsevimab is eventually launched, it will fill a major gap in the prevention of RSV infection. We hope to initiate relevant clinical trials in China as soon as possible and secure early approval, so that all infants and young children in China can benefit.”

SanofiSanofi Pasteur is collaborating with all stakeholders to jointly advance the market launch of Nirsevimab, a preventive monoclonal antibody against respiratory syncytial virus (RSV), in China, thereby protecting hundreds of millions of Chinese children and families from RSV infection.

^[1] Griffin P, Yuan Y, Takas T, et al. Single-Dose Nirsevimab for Prevention of RSV in Preterm Infants. The New England Journal of Medicine, 2020; 383:415-425. DOI: 10.1056/NEJMoa1913556. Available from: https://www.nejm.org/doi/full/10.1056/NEJMoa1913556?query=featured_home

^[2] Adamko DJ, Friesen M. Why does respiratory syncytial virus appear to cause asthma? Journal of Allergy and Clinical Immunology. 2012;130(1):101-102. doi:10.1016/j.ja ci.2012.05.024

^[3] Domachowske JB, Khan AA, Esser MT, et al. Safety, Tolerability, and Pharmacokinetics of MEDI8897, an Extended Half-Life Single-Dose Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. The Pediatric Infectious Disease Journal. September 2018:886-892. doi:10.1097/inf.0000000000001916.

^[4] Centers for Disease Control and Prevention. Respiratory Syncytial Virus (RSV). https://www.cdc.gov/dotw/rsv/index.html#:~:text=Respiratory%20syncytial%20virus%20(RSV)%20is,similar%20to%20the%20common%20cold. Accessed June 2020.

^[5] Shi T, McAllister DA, O’Brien KL, et al. Global, Regional and National Disease Burden Estimates of Acute Lower Respiratory Infections Due to Respiratory Syncytial Virus in Young Children in 2015: A Systematic Review and Modelling Study [J]. Lancet, 2017, 39(10098): 946-958. Available from: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30938-8/fulltext

^[6] American Academy of Pediatrics. Clinical Practice Guideline. The diagnosis, management and prevention of bronchiolitis. Pediatrics 2014; 134:e1474-1502.

^[7] Nair H, et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet. 2010 May 1; 375(9725):1545-55. Available from: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(10)60206-1/fulltext

^[8] Sarah Geoghegan, Anabella Erviti, Mauricio T. Caballero, et al. Mortality due to Respiratory Syncytial Virus. Burden and Risk Factors. American Journal of Respiratory and Critical Care Medicine. June 2016. Volume 195, Issue 1. Available from: https://www.atsjournals.org/doi/full/10.1164/rccm.201603-0658OC

^[9] Karron R. Respiratory Syncytial Virus Vaccines. In: Plotkin SA, Orenstein WA, Offitt PA, Edwards KM, eds. Plotkin’s Vaccines. 7th ed. Philadelphia, PA: Elsevier; 2018: 943 949.

^[10] Kong AM, Krilov LR, Fergie J, et al. The 2014–2015 National Impact of the 2014 American Academy of Pediatrics Guidance for Respiratory Syncytial Virus Immunoprophylaxis on Preterm Infants Born in the United States. Am J Perinatol. 2018; 35(02):192-200.

^[11] Scheltema NM, Gentile A, Lucion F, et al. Global respiratory syncytial virus-associated mortality in young children (RSV GOLD): a retrospective case series[J]. Lancet Glob Health, 2017, 5(10): e984-911. DOI: 10.1016/S2214-109X (17) 30344-3.