Infacort Receives Orphan Drug Designation from FDA for Treatment of Pediatric Adrenal Insufficiency

Industry News

Infacort has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of pediatric adrenal insufficiency (0 through 16 years of age).  Infacort is a new formulation being developed by Diurnal Limited, a specialty pharmaceutical company based in Sheffield, UK.  Adrenal insufficiency is a rare disease characterized by a deficiency in cortisol, an essential hormone for regulating metabolism and the response to stress.  Currently, there is no licensed hydrocortisone preparation for children with this condition.  Infacort is a formulation based on the company’s patented technology that allows the release of cortisol in a reliable and consistent manner.  It is currently in phase III clinical trial to evaluate its safety and efficacy in pediatric adrenal insufficiency.



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