CHMP recommends Ravicti (glycerol phenylbutyrate) Oral Liquid for chronic management of adult and paediatric patients greater than two months of age with Urea Cycle Disorders- Horizon Pharma
Horizon Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion at its monthly meeting in September recommending a centralised marketing authorization for Ravicti (glycerol phenylbutyrate) Oral Liquid for use as an adjunctive therapy for chronic management of adult and pediatric patients greater than two months of age with Urea Cycle Disorders (UCDs).
Ravicti was approved by the FDA in February 2013 for chronic management of adult and pediatric patients ≥ 2 years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. The European Centralised Marketing Authorisation Application for Ravicti included additional data to support an assessment of safety and efficacy in patients greater than two months of age.
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