Atogepant

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Atogepant
Atogepant.svg
Clinical data
Trade names Qulipta, Aquipta
Other namesAGN-241689, MK-8031
AHFS/Drugs.com Monograph
MedlinePlus a621052
License data
Pregnancy
category
Routes of
administration 		By mouth
ATC code
Legal status
Legal status
Identifiers
  • (3S)-N-[(3S,5S,6R)-6-methyl-2-oxo-1-(2,2,2-trifluoroethyl)-5-(2,3,6-trifluorophenyl)piperidin-3-yl]-2-oxospiro[1H-pyrrolo[2,3-b]pyridine-3,6'-5,7-dihydrocyclopenta[b]pyridine]-3'-carboxamide
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
ChEMBL
CompTox Dashboard (EPA)
Chemical and physical data
Formula C29H23F6N5O3
Molar mass 603.525 g·mol−1
3D model (JSmol)
  • 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
  • InChI=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
  • Key:QIVUCLWGARAQIO-OLIXTKCUSA-N

Atogepant, sold under the brand name Qulipta among others, is a medication used to prevent migraines. [4] [5] It is a gepant, an orally active calcitonin gene-related peptide receptor antagonist. [4] [7]

Contents

The most common side effects include nausea, constipation, tiredness, somnolence (sleepiness), decreased appetite, and decreased weight. [5]

Atogepant was approved for medical use in the United States in September 2021, [4] [8] and in the European Union in August 2023. [5] [9]

Medical Uses

Atogepant is indicated for the preventive treatment of episodic migraine in adults. [4] [5]

In the European Union, atogepant (Aquipta) is indicated for prophylaxis (prevention) of migraine in adults who have at least four migraine days per month. [5]

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. [11] Trials 1 and 2 assigned participants to one of several doses of atogepant or placebo daily for three months. [11] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed. [11] 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. [11] The trials were conducted at over 100 sites in the United States. [11] 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. [11]

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]

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Peter GoadsbyFRS FRACP FRCP is an Australian neuroscientist who is Director of the National Institute for Health Research - Wellcome Trust King’s Clinical Research Facility and Professor of Neurology at King's College London. His research has focused particularly on the mechanism and alleviation of migraine and cluster headaches.

References

  1. 1 2 "Aquipta APMDS". Therapeutic Goods Administration (TGA). 20 December 2023. Archived from the original on 2 January 2024. Retrieved 7 March 2024.
  2. ↑ "Summary Basis of Decision for Qulipta". Health Canada . 20 April 2023. Archived from the original on 20 August 2023. Retrieved 20 August 2023.
  3. ↑ "Details for: Qulipta". Health Canada . 24 March 2023. Retrieved 20 August 2023.
  4. 1 2 3 4 5 "Qulipta- atogepant tablet". DailyMed. Archived from the original on 1 November 2021. Retrieved 31 October 2021.
  5. 1 2 3 4 5 6 "Aquipta EPAR". European Medicines Agency (EMA). 25 August 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ↑ "Aquipta Product information". Union Register of medicinal products. 14 August 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023.
  7. ↑ Moreno-Ajona D, Pérez-Rodríguez A, Goadsby PJ (June 2020). "Gepants, calcitonin-gene-related peptide receptor antagonists: what could be their role in migraine treatment?". Current Opinion in Neurology. 33 (3): 309–315. doi:10.1097/WCO.0000000000000806. PMID   32251023. S2CID   215408433.
  8. ↑ "FDA Approves Qulipta (atogepant), the First and Only Oral CGRP Receptor Antagonist Specifically Developed for the Preventive Treatment of Migraine". AbbVie (Press release). 28 September 2021. Archived from the original on 28 September 2021. Retrieved 29 September 2021– via PR Newswire.
  9. ↑ "AbbVie Announces European Commission Approval of Aquipta (atogepant) for the Preventive Treatment of Migraine in Adults" (Press release). AbbVie. 17 August 2023. Archived from the original on 24 August 2023. Retrieved 25 August 2023– via PR Newswire.
  10. ↑ Cornall J (26 June 2023). "AbbVie takes step forward in Europe with migraine drug". Labiotech.eu. Retrieved 26 July 2024.
  11. 1 2 3 4 5 6 7 "Drug Trials Snapshots: Qulipta". U.S. Food and Drug Administration. 28 September 2021. Archived from the original on 25 August 2023. Retrieved 10 September 2023.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  12. ↑ NICE recommends atogepant for preventing episodic and chronic migraine in final draft guidance (Report). 11 April 2024. doi:10.1002/psb.0010155.
  13. ↑ NICE recommends atogepant for preventing episodic and chronic migraine in final draft guidance (Report). 11 April 2024. doi:10.1002/psb.0010155.
  14. ↑ "Study Shows Atogepant Prevents Migraine In Difficult Cases". Pain Medicine News. Retrieved 26 July 2024.
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