25 September 2015 - Horizon Pharma plc, a biopharmaceutical company focused on improving patients' lives by identifying, developing, acquiring and commercializing differentiated and accessible medicines that address unmet medical needs, and its affiliate Horizon Therapeutics Limited today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion at its plenary monthly meeting in September recommending a centralized 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). A full summary of the opinion can be found here. Detailed recommendations for the use of RAVICTI will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

The adopted positive opinion will be considered by the European Commission for a binding decision to be issued for the granting of a centralized marketing authorization within 60 to 90 days from the date of adoption of the opinion.

Ravicti was approved by the U.S. Food and Drug Administration (FDA) in February 2013 for chronic management of adult and pediatric patients greater than or equal to 2 years of age with UCDs who cannot be managed by dietary protein restriction and/or amino acid supplementation alone. The European Centralized Marketing Authorization Application for Ravicti included additional data to support an assessment of safety and efficacy in patients greater than two months of age.

For more details, go to: http://ir.horizon-pharma.com/releasedetail.cfm?ReleaseID=933186