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Rimegepant: First Approval.

Lesley J Scott1

  • 1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.

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This summary is machine-generated.

Rimegepant orally disintegrating tablets (ODT) offer a new acute treatment for migraine. This development marks a significant milestone for Biohaven Pharmaceutical, providing a novel therapeutic option for migraine patients.

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Area of Science:

  • Pharmacology
  • Neurology
  • Drug Development

Background:

  • Rimegepant is a small molecule, selective calcitonin gene-related peptide antagonist.
  • Biohaven Pharmaceutical developed rimegepant for migraine treatment.
  • An orally disintegrating tablet (ODT) formulation of rimegepant exists.

Purpose of the Study:

  • To summarize the development milestones of rimegepant.
  • To highlight the first global approval of rimegepant ODT for acute migraine treatment.

Main Methods:

  • Review of rimegepant's development pathway.
  • Analysis of regulatory milestones leading to FDA approval.

Main Results:

  • Rimegepant ODT received US FDA approval in February 2020.
  • The approval is for the acute treatment of migraine (with or without aura) in adults.
  • A conventional tablet formulation is under investigation for prevention and other indications.

Conclusions:

  • Rimegepant ODT represents a significant advancement in acute migraine therapy.
  • The drug's development journey culminated in a key regulatory approval.
  • Further investigations are ongoing for broader therapeutic applications.