BRIEF—Diurnal to file for Chronocort approval in EU

UK-based Diurnal has agreed on a clinical and regulatory path for Chronocort (hydrocortisone) as a therapy for congenital adrenal hyperplasia (CAH) in Europe.

The European regulator has agreed that no further clinical trials are required and that existing data can be used to support a regulatory submission, which the firm expects to do in the latter part of 2019.

While Diurnal revealed disappointing Phase III data for the therapy in August 2018, a subsequent analysis, together with interim data from an ongoing safety extension study, encouraged the firm to continue to pursue regulatory approval.