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.
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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.
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