SONIA 2 was a 4-year, open-label, evaluator-blind, multicentre, randomised, no treatment controlled, parallel-group study to investigate the efficacy and safety of nitisinone for patients with alkaptonuria.

2019年1月22日 · On the 18th January, the last SONIA 2 (Suitability of Nitisinone In Alkaptonuria 2) patients were seen at the Royal Liverpool and Broadgreen University Hospital.

2019年12月16日 · We are delighted to announce that all the data from the SONIA 2 clinical trial has now been analysed and very positive trends have been highlighted. Due to this, SOBI (Swedish Orphan Biovitrum) announced that they are going to apply to the European Medicines Agency (EMA) for market authorisation for the drug to be used in treating AKU.

The aim of SONIA 2 was to investigate the efficacy and safety of once-daily nitisinone for reducing HGA excretion in patients with alkaptonuria and to evaluate whether nitisinone has a clinical benefit.

Based on the SONIA-2 results, the use of nitisinone (Orfadin R) 10 mg daily has been officially approved by the European Medicines Agency (EMA) in September 2020 for the treatment of adult patients with AKU . The EMA had recommended to use …

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The aim of SONIA 2 was to investigate the efficacy and safety of once-daily nitisinone for reducing HGA excretion in patients with alkaptonuria and to evaluate whether nitisinone has a clinical benefit.

SONIA 2: An international, multicenter, randomized, evaluator-blinded, no-treatment controlled, parallel-group study to assess the efficacy and safety of once daily nitisinone in patients with alkaptonuria after 12 months of treatment, followed by an …

2014年7月30日 · Our SONIA 2 clinical trial is underway at all our sites across Europe. Conducting such a complex trial across three countries is not easy, but the teams at each centre have been working hard to ensure everything runs smoothly. Today we take a look at how the trial is progressing. Recruitment.

The aim of SONIA 2 was to investigate the efficacy and safety of once-daily nitisinone for reducing HGA excretion in patients with alkaptonuria and to evaluate whether nitisinone has a clinical benefit.