Merck announced on December 17, 2024, that the U.S. Food and Drug Administration (FDA) accepted its application seeking approval of clesrovimab, its proposed antibody aimed at protecting infants from respiratory syncytial virus (RSV) disease.
The FDA has set a target action date of June 10, 2025, for a decision. If approved, clesrovimab would be the first and only single-dose immunization for infants, regardless of weight, designed to protect them for their first RSV season.
RSV is a contagious virus and a leading cause of hospitalization for healthy infants. This regulatory milestone positions Merck to potentially launch a new product by July 2025, with shipments arriving in time for the 2025 RSV season.
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