Posted by Michael Wonder on 16 Dec 2019
Diurnal submits marketing application to European regulators for congenital adrenal hyperplasia treatment
16 December 2019 - Significant opportunity to address unmet patient need, in a market estimated at $250 million.
Diurnal Group announces that, in line with expectations, a market authorisation application has been submitted to the EMA for Chronocort (modified release hydrocortisone) as a treatment for adult and adolescent patients with the rare condition congenital adrenal hyperplasia (CAH) in Europe.
The submission follows Diurnal’s Intent to Submit letter in May 2019, which was tendered following a positive meeting with the EMA in March 2019 and written formal Scientific Advice received in April 2019 confirming the clinical and regulatory pathway for Chronocort as a treatment for patients with CAH. The pathway is based on detailed analysis of data from the Company’s Phase 3 study, the largest ever interventional clinical trial in CAH, and an open-label safety extension study. Marketing authorisation of Chronocort in Europe is anticipated in Q1 2021.
