European Commission approves Orfadin oral suspension

EMA

Swedish Orphan Biovitrum AB (Sobi) today announced that the European Commission has approved the oral suspension formulation of Orfadin (nitisinone) for the treatment of Hereditary Tyrosinaemia type-1 (HT-1) as of 19 June 2015. HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney failure and can be fatal if untreated.

 "The European Medicines Agency has called for more child-friendly formulations and the new oral suspension formulation is a demonstration of Sobi's commitment to the needs of the infants and children diagnosed with HT-1 early in life," says Birgitte Volck, Chief Medical Officer of Sobi. "An oral suspension of Orfadin for paediatric use will facilitate accurate dosing for infants and small children, and contribute to improving quality of life for patients and caregivers."

The oral suspension will be made available to patients throughout Europe in H2 2015.

For more details, go to: http://www.sobi.com/en/Investors--Media/News/RSS/?RSS=http://cws.huginonline.com/S/134557/PR/201506/1932326.xml

Michael Wonder

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Michael Wonder

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