Alkermes' Sleep Disorder Drug Receives Orphan Drug Status in US and Europe
MT Newswires Live
Jun 15
Alkermes (ALKS) said Monday that its experimental sleep disorder treatment, alixorexton, received orphan drug designation from US and European regulators.
The company said the US Food and Drug Administration granted orphan status for the treatment of idiopathic hypersomnia, while the European Commission granted the designation for narcolepsy.
Orphan drug designation helps provide regulatory and financial incentives, as well as market exclusivity for rare disease treatments if approved, it added.
Alixorexton is currently being evaluated in phase 3 studies for narcolepsy type 1 and type 2 and a phase 2 study for idiopathic hypersomnia, Alkermes said.
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