ROMA (ITALPRESS) – It arrives in Italy, after the approval of the Italian Agency of the Pharmaco (AIFA), clesrovimab for the prevention of the disease of the lower respiratory tract from sincitial respiratory virus (RSV) in infants at birth or during their first RSV season. Clesrovimab is contraindicated in infants with hypersensitivity to the active ingredient or any of its excipients. Clesrovimab is a monoclonal antibody (mAb) long-acting preventive, designed to offer direct, fast and lasting protection for the entire duration of a typical RSV season, through a single fixed dosage, not based on weight. The approval of the European Commission authorizes marketing in all 27 Member States of the European Union, as well as in Iceland, Liechtenstein and Norway. “The arrival in Italy of Clesrovimab represents a new and important preventive option against the sincidal respiratory virus, one of the main causes of childhood hospitalization that can cause serious bronchiolites and pneumonia both in healthy and risky infants – says Paolo Manzoni, Director of the Department of Maternal-Infantile Medicine of ASLBI, Associate Professor of Pediatrics and Neonatology of the clinical university of Turin and Principal Investigator Thanks to its effectiveness and fixed dosage independent of the weight of the newborn, this innovative resource is able to relieve the weight of the infection on infants, families and hospital departments.” From the clinical effectiveness tested in the laboratory to the everyday reality of families, as explains Nicoletta Luppi, President and CEO Delegate of MSD Italia: “The arrival in Italy of Clesrovimab finally makes available also in our country the new preventive option for infections by Syncidal Respiratory Virus in infants and infants. We will immediately work alongside the competent authorities at all levels, national and regional, to ensure as soon as possible access to this innovation to protect children. Again – he emphasizes – we are proud to support the National Health Service in reducing the clinical and organizational impact of an insidious pathology such as bronchiolite, protecting the health of newborns and offering serenity to their families. Our mission has always been to innovate, especially in the field of prevention and to ensure more life and more quality life to all, from the first breath”. An integrated prevention vision that finds full convergence with the needs and strategies of local prevention departments: “The sinister respiratory virus is one of the most widespread seasonal infections and one of the main causes of child hospitalization in Italy, with a heavy impact on families and the entire National Health Service – underlines Michele Conversano, Consultant of the ASL of Taranto -. The approval by AIFA of Clesrovimab finally makes public health a further effective weapon. The administration with fixed dosage can also guarantee organizational simplicity for our local prevention services: we are ready to integrate this new prophylaxis into our strategic portfolio to protect the health of children. ”The sintric respiratory virus (RSV) is a contagious virus that causes widespread seasonal infections and can lead to severe respiratory conditions such as bronchiolite and pneumonia. As one of the main causes of hospitalization among newborns globally, an unsatisfied need for preventive options against RSV is for healthy and high-risk infants during their first RSV season. The RSV season usually coincides with the period from autumn to spring of the following year. Timing and gravity in a certain community or region may vary year by year. Overall, RSV-related pediatric mortality is estimated at around 101,400 deaths every year in the world. At the Italian level, a multicentric prospectic study that evaluated the clinical presentation and the risk of hospitalization from RSV in children under the age of 5 in different Italian regions during four epidemiological seasons (2019-2020, 2021-2022, 2022-2023 and 2023-2024)3 estimated that RSV was in 40.2% of cases of acute respiratory infection, the frequency of hospitalization was of 44% In addition, the average duration of the disease exceeded two weeks, with 40.9% of children still symptomatic after 14 days and 15.4% after a month. These evidences are consistent with the Italian virological surveillance data of the 2024-2025 season, and confirm the epidemiological relevance of the RSV in the context of pediatric respiratory infections. According to the RespiVirNet network, on 59,674 samples analyzed, the RSV represents in children under 2 years the main pathogen found in the analyzed tampons. “The monoclonal antibodies for the prevention of the Syncidal Respiratory Virus represent one of the most extraordinary goals of pediatric medicine in recent decades, offering a formidable shield to zero or minimize the impact of bronchiolite in infants and infants. This innovation allows to drastically reduce health costs, both in the immediate – reducing deaths, ordinary hospitals and intensive care – and in the long term, preventing chronic complications in adulthood and ensuring the sustainability of our National Health Service – says Rino Agostiniani, President of the Italian Society of Pediatria (SIP) -. For this reason, we welcome Clesrovimab’s approval, a new effective prevention tool available to Italian pediatricians in the universal immunization strategy against RSV.” “The protection of newborns from the Sincitial Respiratory Virus cannot and should not be limited to only winter months. In order to guarantee an equity of protection and a true prevention of proximity, it is essential to immunize even children born outside the epidemic season typical of RSV – says Antonio D’Avino, National President of the Italian Federation of Medici Pediatri (FIMP) . Thanks to the fixed dosage independent of the weight of the child, we can easily protect every newborn directly on the territory from its first days of life, reducing hospitalizations for bronchiolite and raising families from a dangerous threat”. the previous approval of the EC has been supported by the results of the study of Phase 2b/3 CLEVER (MK-1654-004; NCT04767373), in which the safety and effectiveness of a single dose of clesrovimab administered to newborns and term (from birth to 1 year of age), and by the interim data of the first season RS93V of the Phase 3 SM07 Clinical data from CLEVER and SMART studies were published in the New England Journal of Medicine in September 2025.
– MSD press office photos –(ITALPRESS).
