Recommended for EU approval by CHMP - the full indication is "Treatment of congenital adrenal hyperplasia (CAH) in adolescents aged 12 years and over and adults." It should be prescribed by physicians experienced in the treatment of CAH .
Diurnal submit MAA to MHRA .
Filed in the EU .
Diurnal still expect to submit a MAA by end of 2019 .
Diurnal report positive outcome from meeting with EMA to discuss regulatory pathway for Chronocort; no further trials are required. Diurnal intend to submit a EU MAA for Chronocort in Congenital Adrenal Hyperplasia (CAH) Q4 2019 .
Diurnal submit a regulatory package for scientific advice in EU. Subject to the outcome of this advice, the company anticipate filing a MAA Q4 2019 .
The manufacturer, following PIII trial results, said that "...we will now analyse the full data set from this trial, along with interim data from the ongoing Chronocort® long-term dosing study, to determine next steps in Chronocort development, and discuss these with the regulatory authorities.".
Diurnal expect to submit MAA by the end of 2018 .
Two PIII studies in are ongoing in EU - EUDRA CT 2015-005448-32 and EUDRA CT 2015-000711-40 .
Recruitment to two PIII trials (NCT03062280 and NCT02716818) is underway in US .
Diurnal expect to submit a marketing authorisation application for Chronocort® by the end of 2017, with launch in 2018 .
Diurnal are planning a pivotal large multi-centre PIII study, to start in 2015 .
Granted orphan drug status in US .
Granted orphan drug status in EU to treat CAH .