Ravicti® now available for all ages in Europe following approval of the expanded paediatric indication
Swedish Orphan Biovitrum AB (publ) (Sobi™) announces that Ravicti®, a therapy option for the treatment of patients with urea cycle disorders (UCDs), has received approval from the European Commission on 18 December 2018 for the paediatric indication (birth to two months of age) following a positive CHMP opinion from the European Medicines Agency (EMA). The previous indication for Ravicti (glycerol phenylbutyrate) was restricted to children aged more than two months. “This new expanded indication allows all patients access to treatment, which is particularly