Health Canada validates Orfadin® capsule filing
Swedish Orphan Biovitrum AB (publ) (Sobi) announced today that Health Canada has initiated review of the application for approval of Orfadin® (nitisinone) capsules for the treatment of hereditary tyrosinaemia type-1 (HT-1). HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated. “We are very pleased that the review process for Orfadin capsules in Canada has started. Canada and Quebec is home to 10 per cent of the world’s HT-1 population and has been a