A message from Diurnal – Chronocort Development Programme
A message from Diurnal:
CH EU-EU-0060 Date of preparation October 2019
Update for patient groups on Chronocort development programme and timetable
In response to questions we have received from patients, we would like to provide a short update about the plans and timelines for Chronocort marketing in Europe.
Chronocort has been designed to mimic the circadian rhythm of cortisol when given twice daily (last thing at night before sleep and first thing in the morning on waking).
After successful Phase I and II studies, Chronocort did not meet the primary endpoint in its European Phase III trial for the treatment of congenital adrenal hyperplasia (CAH). Diurnal performed further post-hoc analysis of the clinical trial data revealing important differences between Chronocort and the control arm. Formal Scientific Advice from the European Medicines Agency (EMA) confirmed the clinical and regulatory path for Chronocort as a treatment for adult and adolescent patients with CAH.
Thus, Diurnal intends to submit the Marketing Authorisation Application (MAA) in Q4 2019 based on the existing clinical trial data and would anticipate approval in early 2021.
Following a successful marketing authorisation application, Diurnal then intends to file an extension of the Chronocort marketing authorisation for adrenal insufficiency.
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