Posted by Michael Wonder on 02 Dec 2019
Diurnal files adrenal insufficiency drug Alkindi in US
2 December 2019 - Could become only treatment for children with the condition.
UK specialty drug maker Diurnal has filed its Alkindi Sprinkle replacement therapy for children with adrenal insufficiency in the US, a group with few treatment options.
Diurnal said the US marketing application follows a meeting with the FDA which said it would be able to file Alkindi (hydrocortisone granules) under the regulatory pathway for generic drugs, which hinges on showing bioequivalence to standard hydrocortisone tablets.
