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Diurnal, announces European Medicines Agency approval of Paediatric Investigation Plan

Diurnal, announces European Medicines Agency approval of Paediatric Investigation Plan

 

Based in Cardiff Medicentre, Diurnal  Ltd is developing a novel approach to drug delivery that will help patients suffering from reduced levels of the key hormone cortisol (hydrocortisone). Its lead drug Chronocort® is currently in a Phase 2 study at the National Institute of Health (US). Chronocort® has already received two related Orphan Drug designations from the European Medicines Agency, which affords ten years of market exclusivity after the grant of marketing authorisation in Europe.

Chronocort, Diurnal’s most advanced product, has been developed to be used by adults (>18yr) suffering from cortisol deficiency, whilst Infacort® will be developed for the treatment of children under 6 years old suffering a similar inability to produce cortisol.

The problem of effective hydrocortisone replacement is especially acute in this paediatric setting where no licensed therapies exist. Under the Paediatric Investigation Plan, clinical trials will be carried out to provide sufficient evidence of safety and efficacy for Infacort to allow submission of a Paediatric Use Medicines Authorisation (PUMA) to the European Medicines Agency by the end of 2015 and its subsequent use in patients.

Infacort® is being developed by Diurnal and its partners under the EU collaborative research programme – “Treatment of Adrenal Insufficiency in Neonates (TAIN)”. The programme will, for the first time, create a regulatory-approved paediatric version of hydrocortisone


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Published on Wed, 14th Aug 2013

 
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