Posted by Michael Wonder on 03 Aug 2018
European Commission approves extension of indication for Otsuka’s Jinarc (tolvaptan) to include treatment of ADPKD patients with advanced chronic kidney disease (CKD stage 4)
2 August 2018 - Treatment that slows disease progression will now be available for CKD stage 4 patients, where no pharmacological options previously existed.
Otsuka today announced that the European Commission has approved an extension of indication for Jinarc (tolvaptan) to include adult patients with CKD stage 4 autosomal dominant polycystic kidney disease (ADPKD). Jinarc was approved in 2015 for the treatment of ADPKD in adults with CKD stage 1-3 at initiation of treatment and evidence of rapidly progressing disease.
The decision to include stage 4 within the Jinarc licence comes following the submission of additional data from the REPRISE study that supported the safety and efficacy of this treatment in patients with more advanced renal disease.
