UK specialty pharma company Diurnal (AIM: DNL) has taken a major step towards approval of Infacort, the first preparation of hydrocortisone specifically designed for use in children suffering from adrenal insufficiency (AI).
The company has met its primary endpoint in a European Phase III pivotal study of the drug by achieving target cortisol levels in children aged less than six years.
This is seen as a major breakthrough in pediatric AI, a condition of high unmet medical need with no currently licensed formulation for young children in Europe or the USA.
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