Diurnal seeks marketing authorisation for Chronocort (modified-release hydrocortisone) in UK for treatment of patients with congenital adrenal hyperplasia (CAH)
Submission is based on same application to EMA, with a marketing authorisation opinion expected first quarter 2021. Both submissions include an analysis of data from phase III study, the largest ever interventional clinical trial in CAH, and open-label safety extension study.
Source:
PharmaTimes