Sobi receives approval from the FDA for once-daily dosing frequency of Orfadin® for the treatment of HT-1
Swedish Orphan Biovitrum AB (publ) (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. The approval is based on the results of a clinical study in 16 people with hereditary tyrosinaemia type 1 (HT-1), comparing a four week once-daily and four week twice daily dosing regimen. Orfadin is approved in combination with dietary restriction of tyrosine and phenylalanine for people with HT-1, a rare genetic disorder that