Diurnal Group PLC - Cardiff, Wales-based pharmaceutical company focused on hormonal diseases - Submits market authorisation application to the UK Medicines & Healthcare products Regulatory Agency for Chronocort, as a treatment for adult and adolescent patients with the rare condition congenital adrenal hyperplasia in Great Britain.
"The MAA submission follows MHRA guidance following the end of the Brexit Transition Period and follows submission of an MAA to the European Medicines Agency in December 2019, which was subsequently validated by the EMA in April 2020 and has continued along its planned review path with a marketing authorisation opinion for Chronocort approval in the European Economic Area anticipated in the first quarter of 2021," company says.
It adds: "The submission for the MHRA is based on the same application submitted to the EMA in December 2019, including detailed analysis of data from the company's Phase 3 study, an open-label safety extension study of Chronocort and written formal Scientific Advice received in April 2019 confirming the clinical and regulatory pathway for Chronocort as a treatment for patients with CAH."
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By Paul McGowan; paulmcgowan@alliancenews.com
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