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American Focus > Blog > Health and Wellness > Merck’s RSV treatment for infants is approved by FDA
Health and Wellness

Merck’s RSV treatment for infants is approved by FDA

Last updated: June 9, 2025 4:20 pm
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Merck’s RSV treatment for infants is approved by FDA
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A groundbreaking development in the fight against respiratory syncytial virus (RSV) was announced on Monday with the approval of Merck’s clesrovimab, now known as Enflonsia, by the Food and Drug Administration. This monoclonal antibody product is designed to protect infants under the age of 12 months from the severe effects of RSV, offering a new tool in combating this common and dangerous respiratory infection.

Priced at $556 per dose, Enflonsia enters the market at the same price point as its competitor, Beyfortus (nirsevimab) from Sanofi and AstraZeneca. However, Enflonsia offers a unique advantage with a single dosage for all infants, regardless of weight, simplifying the administration process for healthcare providers and families. This streamlined approach may help alleviate some logistical challenges faced during the rollout of other RSV prevention products.

While Enflonsia is currently approved for use only in a child’s first year, Merck is actively conducting studies to potentially expand its authorization to include high-risk infants in their second RSV season. The efficacy of Enflonsia is promising, with a significant reduction in medically attended lower respiratory infections and RSV hospitalizations, providing much-needed relief to families and the healthcare system.

The approval of Enflonsia comes at a time of rapid advancements in RSV prevention, with Pfizer’s Abrysvo vaccine for pregnant individuals also making strides in protecting newborns from RSV. With multiple options now available, healthcare providers have more tools at their disposal to safeguard vulnerable populations against this respiratory virus.

As the availability of Enflonsia begins in July, the upcoming RSV season stands to benefit from this innovative preventive measure. The potential impact of Enflonsia in reducing the burden of RSV-related illnesses underscores the importance of continued research and development in the field of pediatric infectious diseases.

See also  FDA layoffs expected to slow down crucial drug reviews

In light of recent changes within the Advisory Committee on Immunization Practices, the landscape of vaccine recommendations may shift, but the commitment to advancing public health through effective interventions remains steadfast. The approval of Enflonsia marks a significant milestone in the ongoing battle against RSV, offering hope for a future where the impact of this respiratory virus is greatly diminished.

TAGGED:ApprovedFDAinfantsMercksRSVTreatment
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