Atogepant Explained

Tradename:Qulipta, Aquipta
Dailymedid:Atogepant
Pregnancy Au:B3
Routes Of Administration:By mouth
Atc Prefix:N02
Atc Suffix:CD07
Legal Au:S4
Legal Au Comment:[1]
Legal Ca:Rx-only
Legal Ca Comment:[2] [3]
Legal Us:Rx-only
Legal Eu:Rx-only
Legal Eu Comment:[4] [5]
Cas Number:1374248-81-3
Pubchem:72163100
Drugbank:DB16098
Chemspiderid:59718640
Unii:7CRV8RR151
Kegg:D11313
Chebi:196955
Chembl:3991065
Synonyms:AGN-241689, MK-8031
Iupac Name:(3S)-N-[(3''S'',5''S'',6''R'')-6-methyl-2-oxo-1-(2,2,2-trifluoroethyl)-5-(2,3,6-trifluorophenyl)piperidin-3-yl]-2-oxospiro[1''H''-pyrrolo[2,3-b]pyridine-3,6'-5,7-dihydrocyclopenta[b]pyridine]-3'-carboxamide
C:29
H:23
F:6
N:5
O:3
Smiles:C[C@@H]1[C@H](c2c(F)ccc(F)c2F)C[C@H](NC(=O)c2cnc3c(c2)C[C@@]2(C3)C(=O)Nc3ncccc32)C(=O)N1CC(F)(F)F
Stdinchi:1S/C29H23F6N5O3/c1-13-16(22-18(30)4-5-19(31)23(22)32)8-20(26(42)40(13)12-29(33,34)35)38-25(41)15-7-14-9-28(10-21(14)37-11-15)17-3-2-6-36-24(17)39-27(28)43/h2-7,11,13,16,20H,8-10,12H2,1H3,(H,38,41)(H,36,39,43)/t13-,16-,20+,28+/m1/s1
Stdinchikey:QIVUCLWGARAQIO-OLIXTKCUSA-N

Atogepant, sold under the brand name Qulipta among others, is a medication used to prevent migraines. It is a gepant, an orally active calcitonin gene-related peptide receptor antagonist.[6] [7]

The most common side effects include nausea, constipation, tiredness, somnolence (sleepiness), decreased appetite, and decreased weight.

Atogepant was approved for medical use in the United States in September 2021,[8] and in the European Union in August 2023.[9]

Medical Uses

Atogepant is indicated for the preventive treatment of episodic migraine in adults.

In the European Union, atogepant (Aquipta) is indicated for prophylaxis (prevention) of migraine in adults who have at least four migraine days per month.

History

Atogepant was developed by the biopharmaceutical company AbbVie.[10] The benefits and side effects of atogepant were evaluated in two clinical trials of 1,562 participants with a history of migraine headaches occurring on 4 to 14 days per month.[11] The two trials to show the benefits were designed similarly. Trials 1 and 2 assigned participants to one of several doses of atogepant or placebo daily for three months. Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed. The benefit of atogepant was assessed based on the change from baseline in the number of migraine days per month to the last month of the three-month treatment period, comparing participants in the atogepant and placebo groups. The trials were conducted at over 100 sites in the United States. The safety of atogepant was evaluated in 1,958 participants with migraine who received at least one dose of atogepant; therefore, the number of participants representing efficacy findings may differ from the number of participants representing safety findings due to different pools of study participants analyzed for efficacy and safety.

The UK’s National Institute for Health and Care Excellence has issued draft guidance recommending atogepant for preventing episodic and chronic migraine in NHS patients. It's approved for those experiencing at least 4 migraine days per month after failing 3 prior treatments. Atogepant costs £463 monthly but includes a confidential discount.[12]

Research

Atogepant demonstrated efficacy in two phase 3 trials (ADVANCE and PROGRESS) by significantly reducing monthly migraine days, acute medication use, and improving quality of life in patients with episodic and chronic migraine over 12 weeks compared to placebo.[13] Common side effects included nausea, constipation, and fatigue/somnolence.

A study presented at the 2023 meeting for the American Academy of Neurology also showed that atogepant may help prevent migraines in patients who have had no prior success with other preventative drugs.[14]

Notes and References

  1. Web site: Aquipta APMDS . Therapeutic Goods Administration (TGA) . 20 December 2023 . 7 March 2024 . 2 January 2024 . https://web.archive.org/web/20240102015343/https://www.tga.gov.au/resources/auspmd/aquipta . live .
  2. Web site: Summary Basis of Decision for Qulipta . . 20 April 2023 . 20 August 2023 . 20 August 2023 . https://web.archive.org/web/20230820191658/https://dhpp.hpfb-dgpsa.ca/review-documents/resource/SBD1684957849549 . live .
  3. Web site: Details for: Qulipta . . 24 March 2023 . 20 August 2023.
  4. Web site: Aquipta EPAR . European Medicines Agency (EMA) . 25 August 2023 . 25 August 2023 . 25 August 2023 . https://web.archive.org/web/20230825212457/https://www.ema.europa.eu/en/medicines/human/EPAR/aquipta . live . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. Web site: Aquipta Product information . Union Register of medicinal products . 14 August 2023 . 25 August 2023 . 25 August 2023 . https://web.archive.org/web/20230825212748/https://ec.europa.eu/health/documents/community-register/html/h1750.htm . live .
  6. Web site: Qulipta- atogepant tablet . DailyMed . 31 October 2021 . 1 November 2021 . https://web.archive.org/web/20211101041111/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8c8ab8f4-32bd-497a-befa-70c8a51d8d52 . live .
  7. Moreno-Ajona D, Pérez-Rodríguez A, Goadsby PJ . Gepants, calcitonin-gene-related peptide receptor antagonists: what could be their role in migraine treatment? . Current Opinion in Neurology . 33 . 3 . 309–315 . June 2020 . 32251023 . 10.1097/WCO.0000000000000806 . 215408433 .
  8. FDA Approves Qulipta (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine . AbbVie . PR Newswire . 28 September 2021 . 29 September 2021 . 28 September 2021 . https://web.archive.org/web/20210928233843/https://www.prnewswire.com/news-releases/fda-approves-qulipta-atogepant-the-first-and-only-oral-cgrp-receptor-antagonist-specifically-developed-for-the-preventive-treatment-of-migraine-301387297.html . live .
  9. AbbVie Announces European Commission Approval of Aquipta (atogepant) for the Preventive Treatment of Migraine in Adults . AbbVie . PR Newswire . 17 August 2023 . 25 August 2023 . 24 August 2023 . https://web.archive.org/web/20230824082847/https://www.prnewswire.com/news-releases/abbvie-announces-european-commission-approval-of-aquipta-atogepant-for-the-preventive-treatment-of-migraine-in-adults-301903027.html . live .
  10. Web site: Cornall . Jim . 2023-06-26 . AbbVie takes step forward in Europe with migraine drug . 2024-07-26 . Labiotech.eu . en-US.
  11. Web site: Drug Trials Snapshots: Qulipta . U.S. Food and Drug Administration . 28 September 2021 . 10 September 2023 . 25 August 2023 . https://web.archive.org/web/20230825214123/https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-qulipta . live .
  12. NICE recommends atogepant for preventing episodic and chronic migraine in final draft guidance . 2024-04-11 . 10.1002/psb.0010155 . en.
  13. NICE recommends atogepant for preventing episodic and chronic migraine in final draft guidance . 2024-04-11 . 10.1002/psb.0010155 . en.
  14. Web site: Study Shows Atogepant Prevents Migraine In Difficult Cases . 2024-07-26 . Pain Medicine News.