A New Dawn in Infant Health: FDA Approves Groundbreaking RSV Shield, ENFLONSIA™
- FDA greenlights ENFLONSIA™ (clesrovimab-cfor) to shield infants from severe RSV [3, 6].
- One breakthrough dose offers five months of robust protection, simplifying defense against this leading cause of infant hospitalization [2, 6].
- Pivotal trials demonstrate a dramatic over 84% reduction in RSV-linked hospitalizations for protected infants7.
The silent terror of Respiratory Syncytial Virus (RSV) season, a period of dread for parents of newborns, has met a formidable new adversary. On June 9, 2025, the U.S. Food and Drug Administration (FDA) announced its approval of Merck’s ENFLONSIA™ (clesrovimab-cfor), a beacon of hope for protecting the most vulnerable against severe RSV-induced lower respiratory tract disease [3, 7]. This isn't just another approval; it's a paradigm shift in pediatric preventive care.
RSV, the leading cause of infant hospitalization in the U.S., can unleash devastating conditions like bronchiolitis and pneumonia [6, 7]. ENFLONSIA™, a long-acting monoclonal antibody, offers a powerful, direct shield with a single 105 mg dose, providing up to five months of defense – the typical length of an RSV siege – regardless of an infant's weight [2, 6].
"ENFLONSIA combines dosing convenience with strong clinical data showing significant reductions in RSV disease incidence and hospitalizations, making it a promising new intervention," stated Dr. Octavio Ramilo of St. Jude Children’s Research Hospital, an investigator for the crucial CLEVER and SMART trials [4, 6]. Indeed, the CLEVER trial saw ENFLONSIA™ slash medically attended lower respiratory infections by approximately 60% and hospitalizations by an astounding 84.4% compared to placebo7.
With ordering anticipated to begin in July 2025 for the upcoming RSV season, this approval marks a pivotal moment in the fight against a pervasive threat, promising quieter nights for families and eased burdens on healthcare systems [2, 3].
For more information, visit Merck's website. Please see Prescribing Information for ENFLONSIA™ (clesrovimab-cfor) and Patient Information/Medication Guide for ENFLONSIA™.
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