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Diurnal files application for Chronocort in UK, expects approvals in UK, EU in Q1
StockMarketWire.com
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Pharmaceutical company Diurnal sad it had filed a market authorisation application to the UK Medicines and Healthcare products Regulatory Agency for its drug to treat adult and adolescent patients with the rare condition congenital adrenal hyperplasia.
The application in the UK followed an application in the EU to the European Medicines Agency in December 2019, with approval for both applications anticipated in the first quarter of 2021, the company said.
The submission for the MHRA was 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, the company said.
At 9:22am: (LON:DNL) Diurnal Group Plc share price was 0p at 55.5p
Story provided by StockMarketWire.com
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