Diurnal Group - Positive CHMP opinion on Chronocort/Efmody
On 26 March 2021, the EMA announced a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on granting a marketing approval for Efmody, Diurnal’s formulation for controlled release hydrocortisone (developed under the name Chronocort) for the treatment of adults and adolescents aged 12 and over with congenital adrenal hyperplasia (CAH). Formal approval for the product is set to be June 2021 and Diurnal expects to begin commercialisation in calendar Q321.Diurnal Group is a pharma company developing products for the life-long treatment of chronic endocrine conditions. Co. is focused on addressing clinical and patient needs in hormone replacement, initially by developing and marketing products for the rare orphan diseases congenital adrenal hyperplasia and adrenal insufficiency. Co.'s products include Infacort®, an immediate-release hydrocortisone preparation targeting Adrenal Insufficiency (including Congenital Adrenal Hyperplasia) in children under six years of age in Europe and 16 years of age in the U.S.; and Chronocort®, a modified-release hydrocortisone preparation, initially targeting Congenital Adrenal Hyperplasia in adult patients.
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