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Diurnal launches paediatric adrenal treatment in Germany
Pharmaceutical firm Diurnal announced on Tuesday that it has launched its Alkindi product in Germany following the grant of European marketing authorisation in February.
Alkindi is the AIM-traded company's first commercialised medicine and is indicated as replacement therapy of adrenal insufficiency in infants, children and adolescents, and is being targeted for pan-European distribution.
The company said it has already constructed the commercial infrastructure required to support a successful launch of the product.
Oliver Blankenstein of Charité-Universitätsmedizin Berlin and co-investigator in the Phase III clinical trial said: "I am very pleased that this medicine, specifically designed to treat children with adrenal insufficiency, is available in Germany. Lack of specific paediatric medicines is a significant unmet medical need in the paediatric population. Alkindi is the result of an excellent collaboration between the pharmaceutical industry and academia to address the shortfall in paediatric specific medicines."
Alkindi is the first paediatric specific treatment for the condition which is currently treated by compounding hydrocortisone or crushing/splitting tablets of adult preparations of hydrocortisone when present in young patients.
Paediatric adrenal insufficiency is characterised by a lack of cortisol, an essential hormone in regulating metabolism and the response to stress, and is associated with significant morbidity and increased mortality.
Diurnal estimates that there are approximately 4,000 patients in Europe under the age of six who require replacement therapy for adrenal insufficiency due to congenital adrenal hyperplasia, primary adrenal failure or hypopituitarism.
As of 0929 BST, Diurnal Group's shares were unchanged at 195.00p.