ARTICLE | Clinical News

FDA approves once-daily dosing for Orfadin

October 13, 2017 7:45 PM UTC

FDA approved a once-daily dosing regimen for Orfadin nitisinone oral suspension and oral capsules from Swedish Orphan Biovitrum AB (SSE:SOBI) to treat hereditary tyrosinemia type I in patients ages ≥5 who have undetectable serum and urine succinylacetone concentrations after a minimum of 4 weeks on a stable dosage of nitisinone. Hereditary tyrosinemia type I is a rare genetic disorder that can cause liver failure, kidney dysfunction and neurological problems.

FDA approved and recommended twice-daily dosing regimens for the oral capsule formulation in 2002 and the oral suspension formulation in 2016...