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.