(Alliance News) - Diurnal Group PLC on Monday said it has submitted a new drug application for adrenal insufficiency drug Alkindi Sprinkle in the US.
Alkindi Sprinkle consists of hydrocortisone granules in capsules for opening and is intended as a replacement therapy in infants, children and adolescents under 17 years old who have adrenal insufficiency. This condition is characterised by a deficiency in the hormone cortisol and causes chronic fatigue. Without a cortisol replacement, those with the condition are at risk of adrenal crisis and death.
Diurnal had a positive meeting in the first quarter of 2019 with the US Food & Drug Administration, which confirmed Diurnal's regulatory pathway in the US for the drug.
The pathway is based on an Alkindi development programme including a study showing its bioequivalence with a US reference product, as well as a safety and tolerability extension study in Europe.
The pharmaceutical firm said these studies were completed in 2018 and regulatory approval for Alkindi is expected in late 2020.
Diurnal also will request that Alkindi be confirmed as an orphan drug in paediatric adrenal insufficiency, with will require the firm to show significant clinical benefit for Alkinsi Sprinkle versus existing therapies.
Chief Executive Martin Whitaker said: "The submission of a new drug application for Alkindi in the US builds on the successful launch of the product in Europe and further validates our vision of becoming a world-leading endocrinology specialty pharmaceutical company. If approved, Alkindi 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. We look forward to working closely with the FDA to bring this important product to patients."
Shares in Diurnal were down 1.3% at 31.60 pence in London on Monday afternoon.
By Anna Farley; annafarley@alliancenews.com
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