Home » UK Regulators Review Diurnal’s Congenital Adrenal Hyperplasia Therapy
UK Regulators Review Diurnal’s Congenital Adrenal Hyperplasia Therapy
The Diurnal Group is seeking approval from the UK’s Medicines and Healthcare products Regulatory Agency for Chronocort (modified-release hydrocortisone) for treatment of congenital adrenal hyperplasia (CAH), a rare endocrine disorder.
The company is also seeking Orphan Drug status from UK regulators and is expecting a recommendation from the European Medicines Agency early this year on a pending EU marketing authorization.
The most common form of the disease affects one in approximately 10,000 to 15,000 people. “There is a significant need for new therapies to improve outcomes for adult patients with CAH,” said Diurnal’s CEO Martin Whitaker.
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