Diurnal withdraws EMA orphan designation request for Efmody/Chronocort
UK endocrine diseases specialist Diurnal Group (AIM: DNL) has withdrawn its application for maintenance of orphan designation in Europe for Efmody (hydrocortisone modified-release hard capsules), a drug formerly known as Chronocort.
This follows feedback from the Committee for Orphan Medicinal Products (COMP), an advisory committee to the European Medicines Agency (EMA).
Diurnal has decided that continuing pursuit of an orphan designation for the drug would be likely to cause a significant delay in its European commercial launch. First commercial launch is currently anticipated to be in the third quarter of this year.
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