SOBI files for Orfadin oral suspension with EMA

22 August 2013

Swedish Orphan Biovitrum (STO: SOBI) said this morning (August 22) that the company's application for Orfadin (nitisinone) oral suspension has been validated by the European Medicines Agency.

Orfadin is used to treat hereditary tyrosinemia type 1 (HT-1), a rare childhood disease. This new dosage form has been developed to facilitate the ease and accuracy in administration of the desired Orfadin dose to pediatric patients and to increase convenience for the patients and their caregivers.

"We are glad that our application for the Orfadin oral suspension has been accepted by EMA", said Birgitte Volck, senior vice president and chief medical officer at SOBI, adding: "The liquid formulation of Orfadin will facilitate precise dosing for children and should also help increase adherence which is key in any successful treatment."

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