The European Commission has granted a European Marketing Authorisation for DuoCort Pharma's Plenadren, an orphan drug used to treat adrenal insufficiency in adults.
Plenadren, an oral once-daily tablet, is a dual-release hydrocortisone replacement therapy.
The move follows the satisfactory opinion adopted by the Committee for Medicinal Products for Human Use.
DuoCort Pharma chief medical officer Gudmundur Johannsson said Plenadren could be a new cortisol replacement therapy for patients suffering from adrenal insufficiency.
Currently, Plenadren is approved in all European Union countries, Iceland, Norway and Lichtenstein.