Nirsevimab showed a significant reduction in medically-attended lower respiratory tract infections (LRTI) and hospitalisations caused by respiratory syncytial virus (RSV) in healthy preterm infants in a positive Phase IIb trial published in the
The trial demonstrated for the first time that a single-dose monoclonal antibody (mAb) can significantly reduce medically-attended RSV LRTI, including bronchiolitis and pneumonia, in infants throughout the full RSV season.1
Nirsevimab is an extended half-life RSV mAb, being developed by AstraZeneca and
On the primary endpoint, nirsevimab achieved a statistically significant 70.1% reduction in medically-attended RSV LRTI compared to placebo through 150 days post-dose. On the secondary efficacy endpoint, nirsevimab achieved a 78.4% relative reduction in the incidence of hospitalisations due to RSV LRTI compared to placebo through 150 days post-dose. The safety profile for nirsevimab was similar to placebo, with no notable hypersensitivity reactions observed.1
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Serious adverse events were reported in 11.2% of nirsevimab and 16.9% of placebo recipients, and none were considered to be related to nirsevimab.
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RSV
RSV is a common, contagious virus that infects the respiratory tract, causing millions of hospitalisations globally, and is the most common cause of bronchiolitis and pneumonia in children younger than one year in the US.4,5,6 Globally, in 2015, there were approximately 33 million cases of acute lower respiratory infections causing more than three million hospitalisations, and it was estimated that there were 60,000 in-hospital deaths of children younger than five years.5 Approximately 80% of babies who are hospitalised due to RSV are otherwise healthy.7 Moreover, medically-attended LRTIs are associated with increased costs to the healthcare system.5
The Phase IIb trial
Healthy preterm infants of 29-35 weeks' gestation were randomised (2:1) to receive a single 50mg intramuscular injection of nirsevimab or placebo. Between
Nirsevimab
Nirsevimab is an extended half-life RSV mAb being developed as a passive immunisation for the prevention of LRTI caused by RSV. It is being developed for use in a broader infant population than the current standard of care, including for use in all infants experiencing their first RSV season and for infants with congenital heart disease or chronic lung disease entering their first and second RSV season.6,7 While nirsevimab may only require one dose during a typical five-month RSV season, the current anti-RSV antibody, Synagis (palivizumab), is limited to high-risk infants and provides one-month protection, requiring five injections to cover an RSV season.5
Nirsevimab is a passive immunisation, whereby an antibody is given directly to an infant to help prevent RSV, unlike active immunisation, where a person's immune system is activated to prevent or fight infection through a vaccine. Passive immunisation could offer immediate protection unlike active immunisation, which can take weeks to develop protection.8
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AstraZeneca in Respiratory & Immunology
Respiratory & Immunology is one of AstraZeneca's three therapy areas and is a key growth driver for the Company.
Building on a 50-year heritage, AstraZeneca is an established leader in respiratory care across inhaled and biologic medicines. AstraZeneca aims to transform the treatment of asthma and chronic obstructive pulmonary disease (COPD) by eliminating preventable asthma attacks across all severities and removing COPD as a leading cause of death through earlier, biology-led treatment. The Company's early respiratory research is focused on emerging science involving immune mechanisms, lung damage and abnormal cell repair processes in disease and neuronal dysfunction.
With common pathways and underlying disease drivers across respiratory and immunology, AstraZeneca is following the science from chronic lung diseases to immune-driven diseases. The Company's growing presence in immunology is focused on five mid- to late-stage franchises with multi-disease potential in rheumatology (including systemic lupus erythematosus), dermatology, gastroenterology and systemic eosinophilic-driven diseases. AstraZeneca's ambition in immunology is to achieve disease control and ultimately clinical remission in targeted immune-driven diseases.
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