Merck's (MRK) Enflonsia has been approved by the UK's Medicines and Healthcare products Regulatory Agency for the prevention of respiratory syncytial virus lower respiratory tract disease in newborns and infants, the regulator said Wednesday.

The indication is for newborns and infants up to 12 months of age throughout their first RSV season, the regulator said.

The drug is a single injection administered once by a healthcare professional, the regulator said.