Merck receives positive EU CHMP opinion for Enflonsia for RSV in infants
Rahway: Merck, known as MSD outside of the United States and Canada,,has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of ENFLONSIA (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants during their first RSV season.
The CHMP recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway, and a final decision is expected before the end of the year.
“As one of the most pervasive seasonal respiratory infections and a leading cause of infant hospitalization globally, RSV continues to place a significant burden on families and health care systems,” said Dr. Macaya Douoguih, vice president, Therapeutic Area Head, Global Clinical Development, Merck Research Laboratories. “With strong clinical data paired with convenient dosing, this positive opinion recognizes ENFLONSIA as an important new potential option to help protect infants in Europe.”
ENFLONSIA is a preventive, long-acting monoclonal antibody (mAb) designed to provide direct, rapid and durable protection through 5 months, a typical RSV season, with the same dose regardless of infant weight. In most parts of the Northern Hemisphere, including Europe, a typical RSV season usually spans autumn through spring of the next year.
ENFLONSIA should not be administered to infants with a history of serious hypersensitivity reactions, including anaphylaxis, to any component of ENFLONSIA.
The CHMP recommendation is supported by results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) (NCT04767373), which evaluated the safety and efficacy of ENFLONSIA administered to preterm and full-term infants (birth to 1 year of age), and the Phase 3 SMART trial (MK-1654-007) (NCT04938830), which evaluated the safety and efficacy of ENFLONSIA versus palivizumab in infants at increased risk for severe RSV disease. The data from these two pivotal clinical trials were recently published in the New England Journal of Medicine.
ENFLONSIA was approved in the United States and United Arab Emirates in June 2025 and is currently under review in several additional markets globally.
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