Orfadin 20 mg capsules approved in the US

15 June 2016 - Swedish Orphan Biovitrum AB (Sobi) announced today that the FDA has approved a higher strength 20 mg capsule of Orfadin (nitisinone) for the treatment of hereditary tyrosinaemia type-1.

Orfadin is approved in the US and several other countries for the treatment of patients with confirmed diagnosis of hereditary tyrosinaemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. Orfadin, together with the appropriate diet, is an essential part of effective HT-1 treatment.

In April 2016, Sobi announced the approval of the Orfadin oral suspension in the US, thereby providing the possibility to now personalise treatments with five dosing alternatives: 2 mg, 5 mg, 10 mg, 20 mg capsules and 4 mg/ml oral suspension.

For more details, go to: http://www.sobi.com/en/Investors--Media/News/RSS/?RSS=http://cws.huginonline.com/S/134557/PR/201606/2020811.xml

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Orphan drug