17 April 2018 - First and only nitisinone product in Canada approved for once-daily use, designed to meet the needs of HT-1 patients entering older childhood, adolescence and adulthood.
Sobi has received approval from Health Canada for a reduced dosing frequency for Orfadin (nitisinone).
Orfadin is approved in combination with dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1), a rare genetic disorder that may result in liver, renal and neurological complications and in most cases is fatal if untreated. The once-daily reduced dosing frequency is approved for use in patients who weigh 20 kg or more and who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable twice-daily dosage of nitisinone.