Tolvaptan - 'JINARC' - license extension in Europe

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The European Medicines Agency (EMA) has recommended extending the marketing authorisation of tolvaptan - known as JINARC.

On 28 June 2018, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended extending the marketing authorisation (product license) for Jinarc, based on the results of the Reprise clinical trial.

Jinarc is now indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 4 at the start of treatment, with evidence of rapidly progressing disease.

However, at the date of this article, there is no change to the current NICE and Scottish Medicines Consortium prescribing recommendations. In England and Wales, ADPKD patients can be prescribed Jinarc (tolvaptan) if they are at CKD stages 2 to 3 at the start of treatment. In Scotland, patients are eligible at CKD stages 1 to 3 at start of treatment.