Products

Date: 2015-03-18

Type of information: Granting of the orphan status in the US

Product name: Chronocort®

Compound: hydrocortisone modified release capsules

Therapeutic area: Rare diseases - Endocrine diseases - Hormonal diseases

Action mechanism: hormone/corticosteroid. Chronocort® is a modified-release hydrocortisone preparation specifically designed to provide cortisol replacement throughout the day in a manner that mimics, as closely as possible, the natural circadian rhythm (the body’s natural 24 hour hormone cycle) of cortisol.

Company: Diurnal Limited (UK)

Disease: congenital adrenal hyperplasia

Latest news:

• • On March 18, 2015, the FDA has granted orphan drug designation for hydrocortisone modified release capsules for the treatment of congenital adrenal hyperpasia. Diurnal has recently successfully completed a Phase 2 human volunteer study of Chronocort® at the National Institutes of Health Clinical Center, Bethesda, Maryland, which demonstrated the appropriate release profile of hydrocortisone and consequent control of androgens.  Planning is now underway for a large multi-center clinical trial Phase 3 to start in 2015.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA: 2015-03-18

Orphan status UE: 2009-02-03

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes