BRIEF—Diurnal to apply for US approval for Alkindi

London-listed Diurnal says it will submit its Orphan Drug-designated Alkindi (hydrocortisone) for regulatory approval in the USA towards the end of this year.

The firm wants to market Alkindi as a replacement therapy for paediatric adrenal insufficiency (AI), and has completed a study to show bioequivalence with the US reference product.

Chief executive Martin Whitaker said: “If accepted by the FDA, Alkindi will be the first licensed treatment in the USA specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need.”