Alkermes' Alixorexton Gets Orphan Designations

Alkermes plc announced that its investigational drug, alixorexton, an oral selective orexin 2 receptor agonist for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia, received Orphan Drug Designations from the United States — Food and Drug Administration for idiopathic hypersomnia and from the International — European Commission for narcolepsy. These designations offer various incentives, including tax credits, reduced regulatory fees, and market exclusivity for up to seven years in the U.S. and ten years in the EU, if approved. Alixorexton is currently in Phase 3 clinical trials for narcolepsy and a Phase 2 study for idiopathic hypersomnia, building on previous Breakthrough Therapy designation from the United States — Food and Drug Administration for narcolepsy type 1.