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Diurnal Group plc ("Diurnal" or the "Company") US FDA Accepts for Review Diurnal's New Drug Application for Alkindi\u00ae Sprinkle Application seeks approval of Alkindi\u00ae Sprinkle as a replacement therapy of adrenal insufficiency in infants, children and adolescents NDA could potentially be approved in Q3 2020 Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that its New Drug Application (NDA) for Alkindi\u00ae (hydrocortisone granules in capsules for opening), to be known in the US as Alkindi\u00ae Sprinkle, has been accepted for review by the US Food and Drug Administration (FDA). Diurnal is seeking approval of Alkindi\u00ae Sprinkle as a replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents (from birth to <17 years old) in the US. Paediatric AI is a condition characterised by deficiency in cortisol, an essential hormone in regulating growth, metabolism and the response to stress. Paediatric AI has been identified as an orphan disease in the US where there are estimated to over 4,000 sufferers under the age of 17. Untreated, the disease is associated with significant morbidity and increased mortality. The NDA for Alkindi\u00ae Sprinkle was submitted in November 2019 following a positive meeting with the FDA in Q1 2019 which confirmed Diurnal's clinical and regulatory pathway for the product in the US. The PDUFA date set by the FDA, which would be the earliest date at which approval could occur, is 29 September 2020. Martin Whitaker, CEO of Diurnal, commented: "We are pleased to announce that our NDA for Alkindi\u00ae Sprinkle in the US has been accepted for review by the FDA. If approved, Alkindi\u00ae 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." This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR). |
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| aus der Diskussion: | DNL.L (Mkap €25 M) Attraktive Medikamente vor der Zulassung |
| Autor (Datum des Eintrages): | hundadoption (13.02.20 08:10:43) |
| Beitrag: | 371 von 969 (ID:62664877) |
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