(Alliance News) - Diurnal Group PLC said Monday it has submitted a Market Authorisation Application to the European Medicines Agency for its Chronocort product.
Chronocort is a treatment for adult and adolescent patients with the rare condition congenital adrenal hyperplasia.
The pharmaceutical company said the submission follows its Intent to Submit letter in May, which was tendered following a positive meeting with the European Medicines Agency in March and and written formal Scientific Advice received in April, confirming the clinical and regulatory pathway for Chronocort as a treatment for patients with congenital adrenal hyperplasia.
Marketing authorization of Chronocort in Europe is anticipated in the first quarter of 2021, the company said.
In parallel with the submission, Diurnal said it will also apply for confirmation of Orphan Drug Status for Chronocort in congenital adrenal hyperplasia, which requires Diurnal to demonstrate significant clinical benefit for the product compared to existing therapies.
"Should Chronocort be approved, it will provide the potential for life-long treatment, with patients commencing treatment with Alkindi, the company's approved paediatric product, transitioning to Chronocort in adolescence and continuing with Chronocort treatment into later life," Diurnal said.
Chief Executive Officer Martin Whitaker said: "The submission of a Marketing Authorisation Application for Chronocort to the European Medicines Agency is an important step towards the approval of our second product and continues to build our commercial portfolio in endocrinology."
"We believe that Chronocort together with our paediatric product Alkindi has the potential to provide new treatment options for patients with congenital adrenal hyperplasia," Whitaker said.
Diurnal shares were flat in London at 29.50 pence each on Monday.
By Loreta Juodagalvyte; loretajuodagalvyte@alliancenews.com
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