Merck (MRK) said Thursday the US Food and Drug Administration has accepted a supplemental biologics license application to expand Enflonsia's indication.

Merck said the application is to expand Enflonsia's indication to include the prevention of respiratory syncytial virus lower respiratory tract disease in children under two years.

The regulator has set a prescription drug user fee act date of March 22, 2027, the company said.

Last month, the European Medicines Agency accepted an application to expand Enflonsia's marketing authorization in the EU for the same population, Merck said.

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