(Alliance News) - Diurnal Group PLC on Friday said its Efmody drug for congenital adrenal hyperplasia has been approved by the UK regulator.
Efmody was granted a marketing authorisation as a treatment in people aged 12 and older by the Medicines & Healthcare Products Regulatory Agency. The drug had been approved by the EU in May.
Shares in Diurnal were up 1.7% to 65.40 pence in London on Friday morning. They're up 15% year-to-date.
Diurnal said it expects the commercial launch of Efmody in Great Britain in the first quarter of 2022, and it already has started market access activities. The company plans to commercialise the product itself in core markets rather than rely on a partner.
The company said it will not pursue orphan drug status, which would have provided market exclusivity for 10 years, as that would delay the commercial launch. Diurnal holds patents for Efmody which provides "sufficient protection" until at least 2033 in Great Britain.
Congenital adrenal hyperplasia is a condition that causes a deficiency of cortisol, estimated to affect 5,000 patients in the UK.
"We are pleased to have received approval for Efmody from the MHRA and look forward to making Efmody available to CAH patients in Great Britain as the first licensed treatment specifically designed to mimic the physiological circadian rhythm of cortisol," Chief Executive Martin Whitaker said.
By Ivan Edwards; ivanedwards@alliancenews.com
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