10th Aug 2020 11:10
Diurnal Group PLC - Cardiff-headquartered pharmaceutical company - Gets approval for its drug Alkindi in Australia to treat adrenal insufficiency. Australian Therapeutic Goods Administration approves Alkindi, which consists of hydrocortisone granules in capsules for opening, with no age restriction. First Alkindi Australia sales expected in second half of 2021 once pricing and market access activities are complete. Dirunal partners with Emerge Health in Australia and New Zealand, which pursues market and distribution efforts for Alkindi as well as Dirunal's cortisol deficiency drug Chronocort. The total market opportunity for the two drugs in the region is an estimated USD10 million per Annum. Alkindi has orphan drug designation in Australia, which also provides regulatory benefits such as a waiver of application and evaluation fees. Emerge Health now pursuing Alkindi approval in New Zealand. Diurnal expects approval for Chronocort by European Medicines Agency in first 2021 quarter, with dossier then used to submit Chornocort for regulator approval in Australia and New Zealand.
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By Anna Farley; [email protected]
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