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Friday 24 May 2019
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Sobi's Orfadin® oral suspension granted European patent

Swedish Orphan Biovitrum AB (publ) (Sobi) announced that the European Patent Office (EPO) has decided to grant a European patent for the Orfadin® (nitisinone) oral suspension formulation, which was approved by the European Commission for the treatment of Hereditary Tyrosinaemia type-1 (HT-1) in 2015. HT-1 is a rare genetic disease that affects infants and children. It is progressive and may result in liver and kidney complications and can be fatal if untreated.


"Sobi has a long-term commitment to the HT-1 community and work to continuously improve the available treatment options. The oral suspension formulation is a demonstration of this commitment to the needs of the infants and children diagnosed with HT-1 early in life", said Geoffrey McDonough, CEO and President of Sobi. "The oral suspension of Orfadin for paediatric use facilitates dosing accuracy and simplifies ease of use."


Before pharmacological treatment was available, less than one third of infants diagnosed with HT-1 before two months of age lived past their second birthday.1 Treatment with Orfadin combined with dietary restriction of tyrosine and phenylalanine and more widespread newborn screening, leading to early diagnosis have dramatically improved outcomes for HT-1 patients.2


The patent, granted in January 2016, will confer protection to the Orfadin oral suspension formulation in each contracting and extension state to the European Patent Convention (EPC).



  1. van Spronsen FJ et al. Hepatology 1994;20(5):1187–91.
  2. Orfadin EPAR: Product information 25/07/2013  Orfadin - EMEA/H/C/000555 -IB/0045

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