Orphan Drug Plenadren Wins European Marketing Authorisation

DuoCort Pharma's tablet Plenadren for the treatment of adrenal insufficiency has been granted a European Marketing Authorisation.

The European Commission has granted a European Marketing Authorisation for DuoCort Pharma's oral once-daily tablet Plenadren used to treat adrenal insufficiency in adults.

The orphan drug is a dual-release hydrocortisone replacement therapy.

The approval follows the satisfactory opinion adopted by the Committee for Medicinal Products for Human Use. Currently, Plenadren is approved in all European Union countries, Iceland, Norway and Lichtenstein.

DuoCort Pharma chief medical officer Gudmundur Johannsson said Plenadren could be a new cortisol replacement therapy for patients suffering from adrenal insufficiency.