Cardiff, UK - Diurnal Limited (“Diurnal” or “the Company”) today announced that it has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for Infacort®, an oral hydrocortisone formulation for the treatment of paediatric Adrenal Insufficiency (“AI”). The designation provides seven years of market exclusivity in the US after market authorisation and follows the recent Orphan Drug Designation granted by the FDA for Chronocort®, Diurnal’s complementary product for adult Congenital Adrenal Hyperplasia, a related condition.
AI is a condition characterised by deficiency in cortisol, an essential hormone for regulating metabolism and the response to stress. Currently, there are no licensed hydrocortisone preparations in the US to treat young children with AI, with doctors relying on unlicensed preparations compounded from adult tablets. This can result in poor control of the disease, leading to precocious puberty, virilisation and infertility.
Infacort® is a preparation of hydrocortisone specifically designed for use in children suffering from AI. It is an immediate-release, oral formulation of hydrocortisone with the potential to significantly improve the lives of children living with AI.Infacort was recently entered into a pivotal Phase 3 study in Europe which is expected to read out in 2016.
Martin Whitaker, CEO of Diurnal, said:
“Obtaining orphan drug designation from the FDA for Infacort® is an important regulatory milestone for Diurnal and I am very proud of the team in achieving this goal. This second Orphan Drug Designation in the US is an important milestone as Diurnal executes on its goal of becoming the global leader in the development of therapies for diseases of the adrenal gland.”
The Infacort® programme is funded by the European Commission under an EU Framework 7 grant (HEALTH-FP7; Project No: 281654) TAIN “Treatment of Adrenal Insufficiency in Neonates and Infants”. For further information see: www.tain-project.org
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