The U.S. Food and Drug Administration has approved Merck's Enflonsia, a treatment to prevent respiratory syncytial virus lower respiratory tract disease in newborns and infants.
The company said Monday the approval is based on results from its Phase 2b/3 trial evaluating a single dose of the treatment for infants up to one year old.
The trial showed about a 61% reduction in RSV-associated lower respiratory infections or severity compared to a placebo through 5 months. It also demonstrated about an 84% reduction in RSV-associated hospitalizations, showing higher efficacy with increasingly severe cases of disease, the company said.
An advisory committee from the U.S. Centers for Disease Control and Prevention is expected to meet later this month to make recommendations regarding use of the treatment. The company expects orders of the treatment to begin in July, with shipments delivered before the start of the RSV season this fall.
Enflonsia aims to provide rapid protection through 5 months, or a typical RSV season, with the same 105 mg dose regardless of weight, the company said.
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