Diurnal plans first launch of Alkindi for 2Q18 after receiving European marketing authorization
Source - SMW
Diurnal Group plc announced Monday that the European Commission (EC) has granted a paediatric use marketing authorisation (PUMA) for Alkindi following the positive opinion issued by the European Medicines Agency (EMA) in December 2017.
Diurnal said first launch of Alkindi is planned for the second quarter of 2018, and added that it would retain full commercial value of the product and will commercialise Alkindi itself in the major European markets.
Martin Whitaker, Chief Executive Officer of Diurnal, said: 'We are delighted to receive European approval for Alkindi, a significant milestone for Diurnal as our first marketing authorisation.'
'This approval is a major breakthrough for paediatric patients with adrenal insufficiency, with Alkindi being the first licensed treatment in Europe specifically designed for use in these children.'
'Paediatric AI is currently treated by compounding adult preparations of hydrocortisone, which has been approved for more than 50 years. We have a detailed commercial plan in place to bring this important new treatment to paediatric patients and address the current unmet medical need. We anticipate the first launch of Alkindi in Q2 2018.'
At 8:57am: (LON:DNL) Diurnal Group Plc share price was +1p at 174.5p