FDA Approves New RSV Antibody,Enflonsia,for Infant Protection
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The Food and Drug Administration (FDA) approved Merck‘s Enflonsia (clesrovimab) on Monday, a new monoclonal antibody aimed at protecting infants under 12 months from respiratory syncytial virus (RSV). This approval introduces a third option to combat RSV, a common and perhaps severe respiratory illness in young children. Public health experts anticipate that increased competition may eventually lower the cost of these preventative treatments, easing the financial strain on families and the healthcare system.
Enflonsia vs. Beyfortus: Key Differences
Enflonsia enters the market at a wholesale price of $556 per dose, matching the price of its primary competitor, Beyfortus (nirsevimab), developed by Sanofi and AstraZeneca.While the pricing is identical, the two products differ in dosage and approved use cases.
Did You Know?
RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children younger than 1 year in the United States. Most children have been infected with RSV by the time they are 2 years old, according to the Centers for Disease Control and Prevention (CDC).
A key advantage of Enflonsia is its single-dose regimen for all infants, nonetheless of weight, potentially simplifying administration in pediatric offices. Beyfortus, on the other hand, requires different dosages based on an infant’s weight. however, Enflonsia is currently approved only for infants in their first RSV season, while beyfortus is approved for all babies in their first RSV season and for high-risk babies in their second season.
Merck’s Strategy and Future Expansion
Paula Annunziato, Merck’s senior vice president for clinical research, highlighted the logistical simplicity of Enflonsia’s single-dose approach. Merck is also conducting a study comparing Enflonsia to Synagis, an older RSV monoclonal antibody approved only for high-risk infants. Positive results could lead to an expansion of Enflonsia’s approval to include high-risk children in their second RSV season.
Impact on RSV Prevention
Clinical trials have demonstrated that Enflonsia reduces medically attended lower respiratory tract infections caused by RSV by over 60% and lowers RSV-related hospitalization rates by over 84%.These figures underscore the potential of Enflonsia to considerably reduce the burden of RSV on infants and the healthcare system.
the introduction of Enflonsia follows the recent availability of other RSV prevention tools, including Pfizer‘s Abrysvo, a vaccine for pregnant individuals that transfers protective antibodies to the fetus. This vaccine is recommended for pregnant individuals between September and January to protect newborns during RSV season.
Timeline for Enflonsia Availability
Merck anticipates beginning to take orders for Enflonsia in July and shipping doses in time for the 2025 RSV season. The availability of multiple preventative options marks a significant advancement in the fight against RSV, offering diverse strategies to protect vulnerable infants.
| Product | Manufacturer | Dosage | Approved Use | Price (Wholesale) |
|---|---|---|---|---|
| Enflonsia (clesrovimab) | Merck | Single dose for all infants | Infants in their first RSV season | $556 |
| Beyfortus (nirsevimab) | Sanofi/AstraZeneca | Weight-based | All infants in their first RSV season; high-risk infants in their second RSV season | $556 |
| Abrysvo | Pfizer | Vaccine for pregnant individuals | Pregnant individuals during RSV season | N/A |
The Advisory Committee on Immunization Practices (ACIP) was scheduled to vote on recommending Enflonsia at its next meeting in late June. However, recent events, including the replacement of the entire committee, have raised questions about the meeting’s functionality. The Department of Health and Human Services has stated that the meeting will proceed as planned.
Understanding RSV: An Evergreen Viewpoint
Respiratory Syncytial Virus (RSV) is a common respiratory virus that typically causes mild, cold-like symptoms.Though, it can lead to severe illness, especially in infants, young children, and older adults. RSV is a major cause of bronchiolitis and pneumonia in children under one year of age in the United States. The virus spreads through respiratory droplets when an infected person coughs or sneezes. Historically, preventive measures were limited, but recent advancements have introduced vaccines and monoclonal antibodies to protect vulnerable populations.
The progress of preventive tools like vaccines and monoclonal antibodies represents a significant advancement in pediatric care. These interventions aim to reduce the incidence of severe RSV infections, hospitalizations, and associated healthcare costs. The introduction of multiple options, such as maternal vaccines and infant-directed monoclonal antibodies, provides healthcare providers with a range of strategies to protect infants from RSV.
Frequently Asked Questions About Enflonsia and RSV Prevention
Disclaimer: This article provides information about a new medical product. Consult with a healthcare professional for personalized medical advice.
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