Alkermes’ alixorexton secures FDA and EC orphan designations

Alkermes has received ODD from both the FDA and the EC for alixorexton, its investigational OX2R agonist to treat idiopathic hypersomnia and narcolepsy. The FDA granted the status to alixorexton for idiopathic hypersomnia while the EC approved the designation for narcolepsy. Alixorexton is under evaluation in Phase III Brilliance Studies for narcolepsy. Credit: NMK-Studio / Shutterstock.com. Alkermes has received orphan drug designations (ODD) from both the US Food and Drug Administration (FDA) and the European Commission (EC) for alixorexton, its investigational oral orexin 2 receptor (OX2R) agonist to treat idiopathic hypersomnia (IH) and narcolepsy. The FDA granted the status to…

Source: Pharmaceutical Technology