Tolvaptan - 'JINARC' - has been recommended for a license in Europe
The European Medicines Agency (EMA) has recommended granting a marketing authorisation to tolvaptan, which now has the brand name: JINARC.
This means that we are very close to seeing the first-ever licensed drug to treat ADPKD on prescription in the UK! A very exciting and historic moment for everyone affected by PKD.
The EU will make the final decision but we assume that will occur soon - and we hope that the approval of JINARC will stimulate more research into treatments for all forms of PKD, in children as well as adults.
JINARC won't be given to everyone with ADPKD. It is indicated to slow down cyst development and failing kidney function in adult patients with normal to moderately reduced kidney function who have rapidly progressing ADPKD.
In the UK, the NHS will carry out a cost-benefit appraisal to decide whether JINARC can be afforded and given on prescription to patients. We have no way of knowing in advance if that decision will be positive. The appraisal meeting is on 1st April and we should hear by August.