Diurnal Applies For Alkindi Market Authorisation In Australia.
(Alliance News) - Diurnal Group PLC on Wednesday said it has submitted a market authorisation application for adrenal insufficiency drug Alkindi in Australia.
Shares in the pharmaceutical company were up 5.1% at 31.00 pence in late morning trade.
Alkindi was recently given an orphan drug designation in Australia, meaning its application, evaluation, and annual registration fees have been waived.
The drug, which consists of hydrocortisone granules in capsules for opening is indicated for "replacement therapy of adrenal insufficiency in infants, children and adolescents" from birth to the age of 18. Because the capsules can be opened, the dosing can be more easily adjusted for the patient's age.
Paediatric adrenal insufficiency is caused by a lack of the hormone cortisol. It causes chronic fatigue and can result in death if untreated.
Diurnal said its marketing and distribution partner in Australia and New Zealand, Emerge Health Pty Ltd, is seeking registration for Alkindi in both countries. Alkindi has already been approved and marketed in Europe and is the first preparation of hydrocortisone targeted specifically at children with adrenal insufficiency, including the related condition congenital adrenal hyperplasia.
"We are pleased that our partner, Emerge Health, has successfully submitted the market authorisation application for Alkindi in Australia. This builds on the grant of orphan drug designation for Alkindi in Australia received earlier in 2019, which highlights the importance of this product as the first specifically developed and licensed replacement therapy of paediatric adrenal insufficiency designed to address the unmet need in these young patients. We look forward to developing our already successful relationship with Emerge Health as we continue to build our marketing and distribution capabilities in high value markets outside our core territories," said Diurnal Chief Executive Martin Whitaker.
By Anna Farley; email@example.com
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|Date:||Jul 3, 2019|
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