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.
Recent Blog Posts
NHS England and NHS Improvement seeks patients and carers to work with the Quality Surveillance Team
A message from NHS England & NHS Improvement: Did you know that you, as a patient or carer, you can join a team who work to help maintain and improve congenital gynae anomalies services in our hospitals? NHS England and NHS Improvement is calling for patients...
We're pleased to announce the arrival of our long-awaited new Dell laptops! We were extremely lucky to receive a grant for these from The National Lottery Community fund, and thankful too to Dell who worked with us to make this possible. These laptops will enable the...
The CamBABS team at Cambridge University and Cambridge University Hospitals is looking for men and women with classic CAH (either salt wasting or simple virilising) to help with their research. They are conducting a study aimed at understanding how hormone exposure...