Diurnal appoints Clinigen to launch a European Patient Access programme for Infacort® and Chronocort
The Patient Access programme will enable physicians in Europe to prescribe Infacort® and Chronocort® as unlicensed medicines on a Named Patient basis for patients who have no other treatment options, ahead of anticipated European approval and commercial launch of the products.
Infacort® represents the first preparation of hydrocortisone specifically designed for use in children suffering from AI. It is a patented, immediate-release, oral, paediatric formulation of hydrocortisone that allows for age-appropriate dosing in children.
This therapeutic approach has the potential to help young patients less than six year of age suffering from diseases due to cortisol deficiency including adrenal insufficiency and congenital adrenal hyperplasia.
AI requires life-long treatment and Diurnal’s novel approach to product development has the potential to significantly improve these young patients’ lives.
Diurnal has already submitted for market authorisation to the European Medicines Agency via the Paediatric Use Marketing Authorisation (PUMA) route in late 2016.
Chronocort® is a modified release hydrocortisone preparation that has been designed to mimic the natural circadian rhythm of cortisol when given in a twice-a-day “toothbrush” regimen (last thing at night before sleep and first thing in the morning on waking).
Chronocort has been granted orphan drug designations in Europe and the US in the treatment of Congenital Adrenal Hyperplasia (“CAH”) and Adrenal Insufficiency (“AI”).
The first planned indication for Chronocort® is CAH. Chronocort® has completed three Phase I trials in 2011, 2012 and 2015 (food effects study) and a Phase II trial in CAH patients in 2014, and is currently in Phase III trials in Europe.
Diurnal submitted a Paediatric Use Marketing Authorisation (PUMA) application for Infacort® to the European Medicines Agency (EMA) in late 2016. Diurnal anticipates that the EMA review process could take up to one year to complete.
Chronocort® is currently in Phase III clinical development with the trial scheduled to complete in 2018. If the results of the Phase III trial are supportive, Diurnal plans to submit Chronocort® for market approval in Europe.
NB: The current scheme is only for children below 6 years with Adrenal Insufficiency (AI) and adults with congenital adrenal hyperplasia (CAH)
Healthcare Professionals can obtain details about the Infacort® and Chronocort® Patient Access programmes by calling +44 (0) 1283 495 010, or emailing email@example.com
From Press Release 16th March, Diurnal