Diurnal and Clinigen to introduce patient access programme for unlicensed products in Europe
UK-based pharmaceutical company Diurnal has collaborated with Clinigen's IDIS managed access unit to introduce a patient access programme for the former's Infacort and Chronocort to European patients with cortisol deficiency disorders.
The programme will allow physicians to prescribe the products before the European approval and commercial launch, as unlicensed medicines on a named patient basis for patients who do not have any other treatment options.
Diurnal chief executive officer Martin Whitaker said: “Our first product, Infacort, is currently undergoing regulatory review with the EMA.
"Whilst 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.”
Infacort is a hydrocortisone preparation designed for use in children with adrenal insufficiency (AI), or congenital adrenal hyperplasia (CAH), while Chronocort is a modified release hydrocortisone preparation developed to provide a circadian rhythm similar to cortisol for the treatment of adult CAH.
According to Clinigen, its international reach can be leveraged to provide the unlicensed medicines to the patients quickly, safely and ethically.
A paediatric use marketing authorisation (PUMA) application for Infacort has been submitted to the European Medicines Agency last year and Chronocort is currently undergoing a Phase III clinical trial.