(Alliance News) - Diurnal Group PLC on Wednesday said the marketing authorisation application for Chronocort as a treatment for congenital adrenal hyperplasia in Europe has passed validation with the European Medicines Agency.
Congenital adrenal hyperplasia is a condition caused by a block in cortisol production which results in the over-production of male steroid hormones, and can subsequently lead to increased mortality, infertility and issues during sexual development.
The pharmaceutical company said the validation of the application by the regulatory agency allows the formal review process to begin. Dirunal is expecting approval for Chornocort in Europe in the first quarter of 2021.
"We are pleased to announce that our marketing authorisation application for Chronocort has been validated and we look forward to working with the European Medicines Agency during the review process. This is another important step towards the targeted recommendation for approval of our second product in the first quarter of 2021," said Chief Executive Martin Whitaker.
"Following the recent US licensing agreement with Eton Pharmaceuticals for Alkindi Sprinkle and GBP11.2 million placing, Diurnal now has a strong cash position to progress through to and past the anticipated approval date for Chronocort," he added.
Alkindi Sprinkle is a paediatric adrenal insufficiency drug. Paediatric adrenal insufficiency is caused by a lack of the hormone cortisol. It causes chronic fatigue and can result in death if untreated.
The stock was flat at 30.50 pence each on Wednesday afternoon in London.
By Ife Taiwo; ifetaiwo@alliancenews.com
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