- Clinigen Group's Idis managed access division and Diurnal Group have partnered to launch a managed access programme in Europe for Infacort to treat paediatric patients with adrenal insufficiency (AI) and Chronocort to treat patients with congenital adrenal hyperplasia (CAH).

CAH is the most common inherited hormone disorder affecting both men and women. It is caused by genetic mutations of the enzymes in the adrenal gland that synthesise steroid hormones.

Patients with CAH have a deficiency of the stress hormone, cortisol.

Their body's response to this is for the adrenal glands to produce more of the male steroid hormones (androgens), which, in excess levels, are harmful to patients.

Cortisol deficiency and over-production of androgens can lead to increased mortality, infertility and severe development defects, including ambiguous genitalia, precocious puberty and short stature.

Approximately two thirds of CAH patients are estimated to have poor disease control, leading to elevated androgen levels. The condition is estimated to affect approximately 51,000 patients in Europe.

Clinigen chief commercial officer, North America and Europe, Steve Glass, said: "The effective treatment of patients with CAH and paediatric AI represents a significant unmet need.

"As the global leader in providing Managed Access programmes, we can leverage our international reach to support these patients by enabling their physicians to access these therapies safely, ethically and quickly, ahead of approval and launch."

Diurnal chief executive Martin Whitaker said: "Our first product, Infacort, is currently undergoing regulatory review with the EMA. Whilst this is ongoing, we are focused on putting in place the appropriate infrastructure to ensure that patients with cortisol deficiency but no other treatment options can access this medicine as efficiently as possible.

"As a global leader in providing unlicensed medicines to patients on a Named Patient basis, Clinigen is well placed to help us make Infacort and Chronocort® accessible to patients ahead of their potential approval."

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