27 December 2018 - Horizon Pharma today announced the U.S. FDA has approved a supplemental new drug application to expand the age range for Ravicti (glycerol phenylbutyrate) oral liquid to include infants younger than two months of age living with a urea cycle disorder.

A study was conducted to assess safety, efficacy and pharmacokinetics in pediatric patients with UCDs two months of age and younger (n=16). In the study, 10 patients transitioned to Ravicti from sodium phenylbutyrate, three transitioned from intravenous sodium benzoate and sodium phenylacetate, and three were treatment naïve.

Read Horizon Pharma press release