Alkermes receives orphan drug designations for alixorexton
- Alkermes secured orphan drug designations for its investigational sleep disorder treatment alixorexton in both the United States and Europe.
- The designations grant developmental incentives, fee exemptions, and prospective multi-year market exclusivity periods upon potential regulatory approval.
- The regulatory milestones support ongoing late-stage clinical evaluations for narcolepsy and idiopathic hypersomnia targeted for completion this year.
Alkermes plc (NASDAQ:ALKS) announced that its investigational oral medication, alixorexton, was granted orphan drug designations by regulatory authorities in the United States and Europe for rare sleep disorders.
The company is developing the selective orexin 2 receptor agonist to treat patients diagnosed with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.
"These orphan drug designations represent important milestones for the alixorexton program and underscore its potential, if approved, to advance care for the narcolepsy and idiopathic hypersomnia patient communities," said Alkermes Chief Medical Officer and Executive Vice President, Research & Development Craig Hopkinson.
The U.S. Food and Drug Administration granted the status for idiopathic hypersomnia, offering seven years of market exclusivity, while the European Commission granted designation for narcolepsy, offering up to 10 years of exclusivity.
The company plans to utilize these regulatory incentives to advance its ongoing phase 3 Brilliance clinical trials and complete its phase 2 Vibrance-3 study before the end of 2026.
Following the announcement, Alkermes' share price was unchanged at $28.50.
The development program previously secured Breakthrough Therapy designation from the U.S. Food and Drug Administration specifically for the treatment of narcolepsy type 1.
The company continues to expand its broader neuroscience pipeline by enrolling adult participants across multiple global trial sites to evaluate the safety and efficacy of its orexin platform.
