20th Dec 2016 12:23
LONDON (Alliance News) - Diurnal Group PLC on Tuesday said it has submitted a 'paediatric use marketing authorisation' application for Infacort to the European Medicines Agency.
Infacort is a hydrocortisone treatment designed for children suffering from adrenal insufficiency, otherwise known as Addison's disease.
According to Diurnal, the EMA has already approved a paediatric investigation plan for Infacourt and has accepted the PUMA for review.
If approved, Infacort has the potential to be the first licensed treatment in Europe for adrenal insufficiency specifically designed for use in children.
Diurnal anticipates market authorisation in late 2017, with product revenue expected from early 2018.
"This is our first product candidate to be submitted for regulatory approval and marks another important milestone towards building a proprietary endocrinology franchise. If approved, Infacort will be a major breakthrough in the treatment of paediatric adrenal insufficiency, a condition of high unmet medical need with no currently licensed products specifically for young children," Chief Executive Martin Whitaker said in a statement.
Shares in Diurnal were trading up 1.3% at 107.85 pence on Thursday.
By Karolina Kaminska; [email protected]; @KarolinaAllNews
Copyright 2016 Alliance News Limited. All Rights Reserved.
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