New Monoclonal Antibody Clesrovimab Approved in Italy to Protect Infants Against RSV
- Italian health authorities have approved clesrovimab, a long-acting preventive monoclonal antibody designed to protect infants against respiratory syncytial virus, commonly known as RSV, during their first epidemic season.
- The newly approved monoclonal antibody provides direct and lasting protection through a single fixed-dose administration that is independent of the infant's body weight.
- L’arrivo in Italia di clesrovimab rappresenta una nuova e importante opzione preventiva contro il virus respiratorio sinciziale, una delle principali cause di ospedalizzazione infantile che può provocare gravi...
Italian health authorities have approved clesrovimab, a long-acting preventive monoclonal antibody designed to protect infants against respiratory syncytial virus, commonly known as RSV, during their first epidemic season. The Italian Medicines Agency, known as AIFA, cleared the immunization following authorization from the European Commission for all 27 European Union member states, alongside Iceland, Liechtenstein, and Norway, according to reporting by ANSA and Quotidiano Sanità.
Approval and Administration Details of Clesrovimab
The newly approved monoclonal antibody provides direct and lasting protection through a single fixed-dose administration that is independent of the infant's body weight. Quotidiano Sanità reported that clesrovimab is contraindicated only in newborns with hypersensitivity to the active substance or its excipients.
L’arrivo in Italia di clesrovimab rappresenta una nuova e importante opzione preventiva contro il virus respiratorio sinciziale, una delle principali cause di ospedalizzazione infantile che può provocare gravi bronchioliti e polmoniti sia nei neonati sani sia in quelli a rischio.
Paolo Manzoni, Asl di Biella
Corriere della Sera noted that the antibody has been available since October 1 in select Italian regions, including Piedmont, based on regional implementation plans. Michele Conversano, a consultant for the ASL of Taranto, explained to ANSA that the fixed-dose delivery simplifies logistical organization for local prevention services, allowing health agencies to integrate the prophylaxis smoothly into existing pediatric portfolios.
Public Health Impact and Clinical Trial Context
Data compiled from a multicenter prospective study across four epidemiological seasons from 2019 to 2024 showed that RSV accounted for 40.2 percent of acute respiratory infections in children under five years old in Italy. Among those testing positive, the hospitalization rate stood at 4.4 percent with a median hospital stay of five days. Furthermore, symptoms persisted past 14 days in 40.9 percent of infants and past one month in 15.4 percent of cases, according to findings cited by Quotidiano Sanità.
Virological surveillance data from the RespiVirNet network for the 2024 through 2025 season confirmed that out of 59,674 analyzed samples, RSV emerged as the primary pathogen detected in children under two years old. Rino Agostiniani, president of the Italian Society of Pediatrics, told ANSA that the addition of another monoclonal antibody expands choices for family pediatricians rather than replacing current options. Nicoletta Luppi, president and chief executive officer of MSD Italia, remarked to Il Tirreno that the preventive injection functions as a shield for newborns during their earliest days of life.
Siamo qui per dare una risposta ai primissimi giorni di vita dei bambini e delle bambine, un momento in cui potrebbero contrarre il virus respiratorio sinciziale, una patologia che rischia di segnare in maniera negativa il loro primo ingresso nel mondo.
Nicoletta Luppi, MSD Italia
Distribution Timelines and Regional Rollout Strategies
Distribution of clesrovimab to healthcare facilities across Italy is currently underway. Antonio D’Avino, national president of the Italian Federation of Pediatric Doctors, emphasized to ANSA that administering the prophylaxis in October remains essential to ensure infants can combat RSV throughout the winter months, when the virus typically peaks between December and February. For infants born between April and September, administration takes place in vaccination centers or through free-choice pediatricians, whereas newborns delivered during the high-incidence season receive the prophylactic dose directly in the hospital before discharge, as detailed by ANSA.
Clinical backing for the rollout includes interim findings from the phase 3 SMART trial evaluating the safety, efficacy, and pharmacokinetics of clesrovimab compared with palivizumab in infants at higher risk of severe RSV disease. Those clinical outcomes from the CLEVER and SMART trials were published in the New England Journal of Medicine in September 2025, providing the foundational safety and efficacy framework for regulatory evaluations across Europe.