Pharmaceutical company Merck obtains favorable recommendation from the EU's CHMP for ENFLONSIA, aimed at preventing Respiratory Syncytial Virus in infants during their initial seasons.
In a significant development for the healthcare industry, Merck (NYSE: MRK) has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of ENFLONSIA (clesrovimab) for the prevention of Respiratory Syncytial Virus (RSV) in newborns and infants across Europe.
RSV is a contagious virus that causes widespread seasonal infections and can lead to serious respiratory conditions such as bronchiolitis and pneumonia. The RSV season is the time of year when RSV infections are most common, usually occurring autumn through spring of the next year in temperate climates. There is a persisting unmet need for RSV preventive options for both healthy and high-risk infants during their first RSV season in European countries.
ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide protection for 5 months, a typical RSV season, with the same dose regardless of infant weight. It has a 30-month shelf life, ensuring its availability for extended periods in European countries.
The CHMP recommendation is supported by results from the pivotal Phase 2b/3 CLEVER trial (NCT04767373) and the Phase 3 SMART trial (NCT04938830). The most common adverse reactions for ENFLONSIA are injection-site erythema, injection-site swelling, and rash.
AstraZeneca has also applied for EU approval for ENFLONSIA for the prevention of RSV in newborns and infants in the European Union, Iceland, Liechtenstein, and Norway. It is important to note that ENFLONSIA should not be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA.
Merck, a biopharmaceutical company that aspires to be the premier research-intensive company in the world, operates responsibly every day to enable a safe, sustainable, and healthy future for all people and communities in European countries and beyond. ENFLONSIA, Merck's FDA-approved, extended half-life monoclonal antibody (mAb) for passive immunization for RSV prevention in newborns and infants, is currently under review in several additional markets globally.
The CHMP recommendation will be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein, and Norway. Timing and severity of RSV infections can vary year to year, making the availability of effective RSV preventive options crucial in European countries.
In June 2025, ENFLONSIA was approved in the United States and the United Arab Emirates. This latest development brings hope for families and healthcare providers in European countries and beyond, as they await the final decision on ENFLONSIA's EU approval.
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