(Alliance News) - Diurnal Group PLC said Thursday the US Food & Drug Administration accepted for review company's new drug application for Alkindi Sprinkle.
The AIM-listed pharmaceutical company said it is seeking approval of Alkindi Sprinkle as a replacement therapy of adrenal insufficiency in infants, children and adolescents to 17 year old in the US.
Paediatric adrenal insufficiency is a condition, characterized by deficiency in cortisol, an essential hormone in regulating growth, metabolism and the response to stress, the company noted.
The new drug application for Alkindi Sprinkle was submitted in November 2019, following a positive meeting with the FDA in the first quarter of 2019.
The Prescription Drug User Fee Act date, which is set by FDA and which allows to collect fees from drug manufacturers to fund the new drug approval process, is September 29, the company said.
Martin Whitaker, chief executive officer, said: "If approved, Alkindi Sprinkle will provide a major breakthrough in the US as the only licensed treatment specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need."
Diurnal shares were trading flat in London at 28.00 pence each on Thursday.
By Loreta Juodagalvyte; loretajuodagalvyte@alliancenews.com
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