07:36 AM EST, 12/17/2024 (MT Newswires) -- Merck ( MRK ) said Tuesday that the US Food and Drug Administration has accepted its Biologics License Application for clesrovimab, the company's investigational drug to protect infants from respiratory syncytial virus disease during their first season of exposure.

The FDA has set a target action date of June 10 for the drug, a prophylactic long-acting monoclonal antibody, the company said.

The application is supported by results from a phase 2b/3 trial evaluating a single dose of clesrovimab administered to healthy infants and interim results from an ongoing phase 3 trial evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe respiratory syncytial virus disease.

If approved, Merck ( MRK ) anticipates that clesrovimab will be available for order by July, with arrival ahead of next year's respiratory syncytial virus season.