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Atogepant: First Approval
1Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand. dru@adis.com.
Drugs
|November 23, 2021
Summary
Atogepant (Qulipta™) is a new oral medication for preventing episodic migraine. It targets the calcitonin gene-related peptide (CGRP) pathway, offering a novel treatment option for adults with this condition.
Area of Science:
- Neurology
- Pharmacology
- Drug Development
Background:
- Migraine is a prevalent neurological disorder impacting millions globally.
- Current preventive treatments have limitations, necessitating novel therapeutic approaches.
- Calcitonin gene-related peptide (CGRP) pathway is a validated target for migraine prophylaxis.
Purpose of the Study:
- To summarize the development milestones of atogepant (Qulipta™).
- To highlight the regulatory approval of atogepant for episodic migraine prevention.
- To provide an overview of atogepant's journey to market.
Main Methods:
- Review of clinical development data for atogepant.
- Analysis of regulatory submissions and approvals.
- Summary of key trial outcomes and safety profiles.
Main Results:
- Atogepant, an oral CGRP receptor antagonist, demonstrated efficacy in clinical trials.
- The U.S. FDA approved atogepant in September 2021 for episodic migraine prevention in adults.
- Phase 3 trials are ongoing in various international regions.
Conclusions:
- Atogepant represents a significant advancement in oral migraine prophylaxis.
- The approval marks a milestone in CGRP-targeted therapies.
- Further development aims to expand access to this treatment globally.
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