Health Canada OK’s Sobi’s rare disease drugNovember 27, 2017
Swedish Orphan Biovitrum has received approval from Health Canada for an oral suspension formulation of Orfadin (nitisinone).
Orfadin is a medicine approved in multiple countries across North America and Europe for use in combination with dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinaemia type 1 (HT-1), a rare genetic disorder that can cause liver, renal and neurological complications and in most cases is fatal if untreated.
“The introduction of new nitisinone dosing options, such as Orfadin oral suspension, is the result of Sobi listening to feedback from patients and caregivers and continuing to innovate to meet their needs,” says Bob McLay, Vice President and General Manager of Sobi Canada Inc. “In various markets around the world where Sobi has already introduced multiple innovative Orfadin formulations such as Orfadin oral suspension and Orfadin 20 mg capsules, we have seen patients increasingly choose these dosing options over the first-generation capsules, so we are excited to be able to offer a choice to patients in Canada as well.”
Both Orfadin oral suspension and Orfadin 20 mg capsules are available in Canada, as well as the original 2 mg, 5 mg and 10 mg capsules.