LONDON, UK: Diurnal Group announced the commercial launch of Efmody (hydrocortisone modified-release hard capsules) in the United Kingdom as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH). The launch of Efmody follows its approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in…
LONDON: Diurnal Group plc announced the launch of Efmody (hydrocortisone modified-release hard capsules) in Germany and Austria as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH), following approval by the European Commission in May 2021. Following the launch of Alkindi (hydrocortisone granules in capsules for…
LONDON, UK: Diurnal Group plc announced the US Food and Drug Administration (FDA) has agreed a Special Protocol Assessment (SPA) for Chronocort (modified-release hydrocortisone) for the design, endpoints and statistical analysis approach of a pivotal study of Chronocort for the treatment for Congenital Adrenal Hyperplasia (CAH) in the US. The SPA provides agreement that the…