UK-based specialty pharma company Diurnal and global pharma services company Clinigen have partnered to launch a Managed Access programme in Europe.
The program will treat paediatric patients with adrenal insufficiency (AI) and congenital adrenal hyperplasia (CAH). Infacort will be used to treat AI and Chronocort for CAH.
Run by the Idis Managed Access (MA) division of Clinigen, the Managed Access programme will enable physicians in the European Union to access Infacort and Chronocort as unlicensed medicines on an individual named patient basis.
This access is ahead of European approval and commercial launch. It is for patients who have no other treatment options.
Steve Glass, Clinigen Chief Commercial Officer of North America and Europe, said:
We can enable physicians to access these therapies safely, ahead of approval and launch.
“The effective treatment of patients with CAH and paediatric AI represents a significant unmet need. We can enable physicians to access these therapies safely, ethically and quickly, ahead of approval and launch.”
Martin Whitaker, Chief Executive Officer of Diurnal said:
“Our first product, Infacort, is currently undergoing regulatory review with the EMA. While this is ongoing, we are focused on putting in place the appropriate infrastructure to ensure that patients with cortisol deficiency but no other treatment options can access this medicine as efficiently as possible.”
“As a global leader in providing unlicensed medicines to patients on a Named Patient basis, Clinigen is well placed to help us make Infacort and Chronocort accessible to patients ahead of their potential approval.”
