Alkindi® is the first preparation of hydrocortisone specifically designed for use in children suffering from paediatric adrenocortical insufficiency (AI). Alkindi® is a patented, oral, immediate-release paediatric formulation of hydrocortisone granules in capsules for opening that allows for accurate age-appropriate dosing in children. This therapeutic approach has the potential to help young patients less than eighteen years of age suffering from pediatric AI and the related condition congenital adrenal hyperplasia (CAH).
Alkindi® is already approved and marketed in the European Union. On September 29th, 2020 the US Food and Drug Administration (FDA) has also approved Alkindi® for AI.
EffRx has recently submitted to Swissmedic (Switzerland) a Marketing Authorization Application for the registration of Alkindi®. If approved, this new treatment is expected to be available on the Swiss market by 2022. In Switzerland there are approximately 200 patients suffering from pediatric AI.