Adnkronos (Adnkronos) – Following approval by AIFA, the Italian Medicines Agency, clesrovimab is now available in Italy for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in newborns at birth or during their first RSV season. “The drug,” MSD informs in a statement, “is contraindicated in newborns with hypersensitivity to the active ingredient or to any of its excipients.
Clesrovimab is a long-acting, prophylactic monoclonal antibody (mAb) designed to provide direct, rapid, and durable protection throughout a typical RSV season through a single, fixed, non-weight-based dose. The European Commission (EC) approval authorizes its marketing in all 27 member states of the European Union (EU), as well as Iceland, Liechtenstein, and Norway.
"The arrival of clesrovimab in Italy represents an important new preventive option against respiratory syncytial virus, a major cause of infant hospitalization that can cause severe bronchiolitis and pneumonia in both healthy newborns and those at risk," comments Paolo Manzoni, director of the Department of Maternal and Child Medicine at the ASLBI, associate professor of Pediatrics and Neonatology at the University of Turin, and principal investigator of the SMART clinical trial.
“Thanks to its efficacy and fixed dosage independent of the newborn's weight, this innovative resource is able to alleviate the burden of infection on newborns, families and hospital wards.”
As Nicoletta Luppi, President and CEO of MSD Italia, explains, "The arrival of clesrovimab in Italy finally makes this new preventive option for respiratory syncytial virus infections in newborns and infants available in our country. We will immediately work alongside the relevant authorities at all levels, national and regional, to ensure access to this innovation as quickly as possible to protect our youngest children. Once again," she adds, "we are proud to support the National Health Service in reducing the clinical and organizational impact of an insidious disease like bronchiolitis, protecting the health of newborns and offering peace of mind to their families. Our mission has always been to innovate, particularly in the field of prevention, and to ensure longer and better-quality lives for everyone, from their first breath."
The concept of integrated prevention fully aligns with the needs and strategies of local prevention departments. "Respiratory syncytial virus," emphasizes Michele Conversano, consultant for the Taranto Local Health Authority, "is one of the most widespread seasonal infections and a leading cause of childhood hospitalization in Italy, with a severe impact on families and the entire National Health Service. AIFA's approval of clesrovimab finally provides public healthcare with another effective tool. Fixed-dose administration can also ensure organizational simplicity for our local prevention services: we are ready to integrate this new prophylaxis into our strategic portfolio to protect the health of our youngest patients."
RSV is a contagious virus that causes widespread seasonal infections and can lead to serious respiratory conditions such as bronchiolitis and pneumonia. It is a leading cause of hospitalization among newborns globally, according to the statement. Therefore, there is an unmet need for preventive options for both healthy and high-risk newborns during their first RSV season, which typically occurs from fall to spring the following year. The timing and severity in a given community or region may vary from year to year.
Overall, RSV-related pediatric mortality is estimated at approximately 101.400 deaths annually worldwide. In Italy, a prospective multicenter study evaluating the clinical presentation and risk of RSV-related hospitalization in children under 5 years of age in different Italian regions over four epidemiological seasons (from 2019 to 2024) estimated that RSV was involved in 40,2% of cases of acute respiratory infection. The hospitalization rate was 4,4% in RSV-positive subjects, and the median hospital stay was 5 days. Furthermore, the average duration of illness exceeded 2 weeks, with 40,9% of children still symptomatic after 14 days and 15,4% after one month. These findings are consistent with Italian virological surveillance data from the 2024–2025 season and confirm the epidemiological relevance of RSV in pediatric respiratory infections. According to the RespiVirNet network, out of 59.674 samples analyzed, RSV is the main pathogen detected in children under 2 years of age.
"Monoclonal antibodies for the prevention of respiratory syncytial virus (RSV) represent one of the most extraordinary achievements in pediatric medicine in recent decades, offering a formidable shield to eliminate or minimize the impact of bronchiolitis in newborns and infants," emphasizes Rino Agostiniani, president of the Italian Society of Pediatrics (SIP). "This innovation allows for drastic reductions in healthcare costs, both in the short term—by reducing deaths, hospitalizations, and intensive care—and in the long term, by preventing chronic complications in adulthood and ensuring the sustainability of our National Health Service. For this reason, we welcome the approval of clesrovimab, an effective new prevention tool available to Italian pediatricians as part of the universal RSV immunization strategy."
Protecting newborns from respiratory syncytial virus "cannot and must not be limited to the winter months alone," observes Antonio D'Avino, national president of FIMP, the Italian Federation of Pediatricians. "To ensure equitable protection and true community-based prevention, it is essential to also immunize children born outside the typical RSV epidemic season. Long-acting monoclonal antibodies like clesrovimab offer family pediatricians an extraordinarily flexible and effective tool. Thanks to the fixed dose regardless of the child's weight, we can easily protect every newborn directly in the community from their first days of life, reducing hospitalizations for bronchiolitis and relieving families of a dangerous threat."
The EC's previous approval – the statement concludes – was supported by results from the pivotal Phase 2b/3 Clever study, which evaluated the safety and efficacy of a single dose of clesrovimab administered to preterm and term infants (from birth to 1 year of age), as well as interim data from the first RSV season of the Phase 3 Smart study, which evaluated the safety, efficacy, and pharmacokinetics of clesrovimab compared to palivizumab in infants at increased risk of severe RSV disease. Clinical data from the Clever and Smart studies were published in the New England Journal of Medicine in September 2025.
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