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FDA Approved Drugs: Changes to Approved Drugs01:26

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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Lemborexant: First Approval.

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Lemborexant, a dual orexin receptor antagonist, is approved for treating insomnia in adults. It targets sleep onset and maintenance issues and is also being studied for Alzheimer's-related sleep disorders.

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Area of Science:

  • Pharmacology
  • Sleep Medicine

Background:

  • Insomnia is a prevalent sleep disorder affecting sleep onset and maintenance.
  • Orexin receptor (OXR) antagonists represent a novel therapeutic approach for insomnia.

Purpose of the Study:

  • To summarize the development milestones of lemborexant.
  • To highlight the drug's journey to its first global approval for insomnia.

Main Methods:

  • Review of lemborexant's discovery and development process.
  • Analysis of regulatory approvals in key markets.

Main Results:

  • Lemborexant, a dual OXR antagonist, was developed by Eisai Inc.
  • Received US FDA approval in December 2019 and Japanese PMDA approval in January 2020 for insomnia.
  • Investigational use for irregular sleep-wake rhythm disorder in Alzheimer's disease.

Conclusions:

  • Lemborexant's development signifies a significant advancement in insomnia treatment.
  • The drug's dual orexin receptor antagonism offers a targeted mechanism for sleep regulation.