Skip to main content
SpringerLink
Log in

Atogepant: First Approval

  • AdisInsight Report
  • Published:
Drugs Aims and scope Submit manuscript

Abstract

Atogepant (Qulipta™) is an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist being developed by AbbVie for the prophylaxis of migraine. In September 2021, atogepant was approved in the USA for the preventive treatment of episodic migraine in adults. The drug is also in phase 3 clinical development for the preventive treatment of migraine in various other countries. This article summarizes the milestones in the development of atogepant leading to this first approval for the preventive treatment of episodic migraine in adults.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Similar content being viewed by others

References

  1. Eigenbrodt AK, Ashina H, Khan S, et al. Diagnosis and management of migraine in ten steps. Nat Rev Neurol. 2021;17(8):501–14.

    Article  Google Scholar 

  2. de Vries T, Villalón CM, MaassenVanDenBrink A. Pharmacological treatment of migraine: CGRP and 5-HT beyond the triptans. Pharmacol Ther. 2020;211: 107528. https://doi.org/10.1016/j.pharmthera.2020.107528.

    Article  CAS  PubMed  Google Scholar 

  3. Chan C, Goadsby PJ. Recent advances in pharmacotherapy for episodic migraine. CNS Drugs. 2019;33(11):1053–71.

    Article  CAS  Google Scholar 

  4. AbbVie. QULIPTA (atogepant) tablets, for oral use: US prescribing information. 2021. https://www.accessdata.fda.gov. Accessed 30 Sept 2021.

  5. AbbVie. FDA approves QULIPTA™ (atogepant), the first and only oral CGRP receptor antagonist specifically developed for the preventive treatment of migraine [media release]. 28 Sept 2021. https://news.abbvie.com.

  6. Allergan and Merck Co. Allergan enters into licensing agreement with Merck to obtain exclusive worldwide rights to CGRP migraine development program [media release]. 7 July 2015. http://www.allergan.com.

  7. Rubio-Beltran E, Chan KY, Danser AJ, et al. Characterisation of the calcitonin gene-related peptide receptor antagonists ubrogepant and atogepant in human isolated coronary, cerebral and middle meningeal arteries. Cephalalgia. 2020;40(4):357–66.

    Article  Google Scholar 

  8. Melo-Carrillo A, Strassman AM, Schain AJ, et al. Combined onabotulinumtoxinA/atogepant treatment blocks activation/sensitization of high-threshold and wide-dynamic range neurons. Cephalalgia. 2021;41(1):17–32.

    Article  Google Scholar 

  9. Boinpally R, McNamee B, Yao L, et al. A single supratherapeutic dose of atogepant does not affect cardiac repolarization in healthy adults: results from a randomized, single-dose, phase 1 crossover trial. Clin Pharmacol Drug Dev. 2021;10(9):1099–107.

    Article  CAS  Google Scholar 

  10. Min KC, Kraft WK, Bondiskey P, et al. Atogepant is not associated with clinically meaningful alanine aminotransferase elevations in healthy adults. Clin Transl Sci. 2021;14(2):599–605.

    Article  CAS  Google Scholar 

  11. Rowe J, Chan H, Chandrasekar P, et al. Mass balance and metabolism of carbon-14 atogepant in healthy male participants [abstract]. Neurology. 2021;96(15 Suppl).

  12. Boinpally R, Jakate A, Butler M, et al. Single-dose pharmacokinetics and safety of atogepant in adults with hepatic impairment: results from an open-label, phase 1 trial. Clin Pharmacol Drug Dev. 2021;10(7):726–33.

    Article  CAS  Google Scholar 

  13. Boinpally R, Spaventa J, Chen K, et al. Evaluation of the pharmacokinetic interaction and safety of atogepant co-administered with acetaminophen or naproxen in healthy participants: a randomized trial. Clin Drug Investig. 2021;41(6):557–67.

    Article  CAS  Google Scholar 

  14. Boinpally R, Butler M, Rojo J, et al. Evaluation of the pharmacokinetic interaction and safety of atogepant coadministered with esomeprazole magnesium [abstract no P-127]. Headache. 2021;61(Suppl 1):94–5.

    Google Scholar 

  15. Ankrom W, Xu J, Vallee MH, et al. Atogepant has no clinically relevant effects on the pharmacokinetics of an ethinyl estradiol/levonorgestrel oral contraceptive in healthy female participants. J Clin Pharmacol. 2020;60(9):1157–65.

    Article  CAS  Google Scholar 

  16. Boinpally R, Jakate A, Butler M, et al. Coadministration of single therapeutic oral doses of atogepant and sumatriptan produces no clinically relevant drug-drug interactions [abstract]. Headache. 2020;60(Suppl 1):35.

    Google Scholar 

  17. Boinpally R, Forsythe C, Borbridge L, et al. Evaluation of pharmacokinetic interactions and safety of atogepant coadministered with quinidine gluconate [abstract]. Neurology. 2021;96(15 Suppl 1).

  18. Ailani J, Lipton RB, Goadsby PJ, et al. Atogepant for the preventive treatment of migraine. N Engl J Med. 2021;385(8):695–706.

    Article  CAS  Google Scholar 

  19. Schwedt TJ, Lipton RB, Ailani J, et al. Time course of efficacy of atogepant for the preventive treatment of migraine: results from the randomized, double-blind ADVANCE trial. Cephalalgia. 2021. https://doi.org/10.1177/03331024211042385.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Goadsby PJ, Dodick DW, Ailani J, et al. Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial. Lancet Neurol. 2020;19(9):727–37.

    Article  CAS  Google Scholar 

  21. Ashina M, Tepper SJ, Reuter U, et al. Atogepant 60 mg once-daily shows efficacy for the preventive treatment of migraine: results from a 52-week open- label extension trial [abstract no. P-133]. Headache. 2021;61(Suppl 1).

  22. Lipton RB, Halker Singh RB, Mechtler LL, et al. Daily dosing of atogepant for preventive treatment of migraine improved patient-reported outcomes measures of migraine-specific quality of life, activity impairment in migraine-diary, and headache-impact test in a 52-week trial [abstract no. P-203]. Headache. 2021;61(Suppl 1):119–20.

  23. Ashina M, Tepper S, Reuter U, et al. Long-term safety and tolerability of atogepant 60 mg following once daily dosing over 1 year for the preventive treatment of migraine [abstract]. Neurology. 2021;96(15 Suppl 1).

Download references

Author information

Authors and Affiliations

  1. Springer Nature, Mairangi Bay, Private Bag 65901, Auckland, 0754, New Zealand

    Emma D. Deeks

Authors
  1. Emma D. Deeks
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Emma D. Deeks.

Ethics declarations

Funding

The preparation of this review was not supported by any external funding.

Authorship and Conflict of interest

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Emma Deeks is a contracted employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Ethics approval, Consent to participate, Consent to publish, Availability of data and material, Code availability

Not applicable.

Additional information

This profile has been extracted and modified from the AdisInsight database. AdisInsight tracks drug development worldwide through the entire development process, from discovery, through pre-clinical and clinical studies to market launch and beyond.

Supplementary Information

Below is the link to the electronic supplementary material.

Supplementary file1 (PPTX 502 kb)

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Deeks, E.D. Atogepant: First Approval. Drugs 82, 65–70 (2022). https://doi.org/10.1007/s40265-021-01644-5

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40265-021-01644-5

Search

Navigation