Diurnal is a member of the TAIN Consortium, a collaborative European research programme whose goal is to create a new, innovative, regulatory approved version of hydrocortisone – Infacort® - that can be administered in adrenal insufficiency patients from birth and specifically in the age range 0-6 years.
Hydrocortisone is an essential glucocorticoid hormone used as a replacement therapy for the treatment of the rare disease Adrenal Insufficiency – a condition where the body cannot produce sufficient levels of cortisol. The problem of effective hydrocortisone replacement is especially severe in neonates and infants, as no licensed therapy currently exists.
Successful development of Infacort® (commercial name Alkindi® (hydrocortisone in capsules for opening)) will address this major unmet patient need, first in Europe, and then globally and will contribute to the EURODIS goals of having 200 orphan drug approved in Europe by 2020.
TAIN stands for Treatment of Adrenal Insufficiency in Neonates and Infants and is supported and funded by the European Commission through its 7th Framework Programme (Project Number 281654). TAIN brings together European experts in drug development, SMEs and paediatric endocrinologists to develop this new therapy for patients.
The TAIN Project was successfully completed on the 30th November 2016 with the submission of a Paediatric Use Market Authorisation (PUMA) application to the European Medicines Agency. If successful this will be the first PUMA application funded by the European Commission that has resulted in a new paediatric medicine being approved in Europe.
Visit the TAIN Project website for further information and project updates.