Open-label, Multicentre, Multiple-dose Trial to Evaluate Pharmacokinetics, Efficacy and Safety of Once Daily Dosing Compared to Twice Daily Dosing of Orfadin in Patients Diagnosed With Hereditary Tyrosinemia Type 1
Phase of Trial: Phase III
Latest Information Update: 05 Sep 2017
At a glance
- Drugs Nitisinone (Primary)
- Indications Tyrosinaemia type I
- Focus Pharmacokinetics
- Sponsors Swedish Orphan Biovitrum
- 05 Sep 2017 According to a Swedish Orphan Biovitrum media release, Sobi has received approval from the U.S. Food and Drug Administration (FDA) for a reduced dosing frequency for Orfadin (nitisinone) from twice daily to once daily in patients 5 years of age and older.
- 02 Feb 2017 According to Swedish Orphan Biovitrum media release, Sobi has received confirmation by the European Commission (EC) approving a reduced dosing frequency for Orfadin (nitisinone) from twice daily to once daily in people with hereditary tyrosinemia type 1 (HT-1) with a body weight >20 kg.
- 10 Nov 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.