FDA approves new dosing option for Orfadin (nitisinone) in Hereditary Tyrosinemia Type 1- Swedish Orphan Biovitrum

The FDA has approved Orfadin (nitisinone) 20 mg Capsule, from Swedish Orphan Biovitrum, for the treatment of Hereditary Tyrosinemia Type 1 (HT-1). This is the second time this year Sobi is expanding the Orfadin dosing options for HT-1 patients. Orfadin is indicated for use in combination with dietary restriction of tyrosine and phenylalanine.

Treatment with Orfadin is weight-based. As patients grow, they will need progressively higher doses. Having a higher strength capsule may help minimize the number of capsules needed to achieve treatment levels of adolescent and adult patients.

Earlier this year, Sobi announced the approval of Orfadin Oral Suspension. With the availability of the 20 mg Capsule, physicians can further personalize treatment, whether they are infants or adults. ORFADIN is available in capsules (2 mg, 5 mg, 10 mg, and 20 mg) and oral suspension (4 mg/mL).