LONDON, UK: Diurnal Group announced the commercial launch of Efmody (hydrocortisone modified-release hard capsules) in the United Kingdom as treatment of adult and adolescent patients (12 years and older) with the rare condition congenital adrenal hyperplasia (CAH).
The launch of Efmody follows its approval by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in Great Britain (England, Wales and Scotland) in July 2021.
Consistent with the Company’s European commercialisation strategy, Diurnal is marketing Efmody in the UK with its own salesforce.
In parallel to this launch and following the recent launch in Germany and Austria on 1 September, Diurnal is currently in discussions with various health authorities across the European Economic Area to ensure timely launches in other major European countries.
Launch stocks of Efmody have been manufactured in advance of the planned launches in order to provide timely availability of the product, utilising many aspects of the supply chain that have already been established by the Company for Alkindi.
Efmody is a preparation of hydrocortisone that has been specifically designed for patients with CAH, a rare condition caused by deficiency of adrenal enzymes, most commonly 21-hydroxylase.
Approximately two-thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect a total of approximately 5,000 patients in Great Britain.
Martin Whitaker, Chief Executive Officer of Diurnal, commented: “We are delighted to have launched Efmody in the UK. Efmody provides a new treatment option for patients suffering with CAH in Great Britain, and we look forward to being able to provide Efmody to these patients.”
Diurnal Group plc is a European, UK-headquartered, specialty pharmaceutical company dedicated to developing hormone therapeutics to aid lifelong treatment for rare and chronic endocrine conditions, including congenital adrenal hyperplasia, adrenal insufficiency, hypogonadism and hypothyroidism. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.
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