Alkermes' Sleep Disorder Drug Receives Orphan Drug Status in US and Europe

MT Newswires Live
06/15

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.

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10