Galcanezumab

Last updated

Galcanezumab
Emgality.jpg
Monoclonal antibody
Type Whole antibody
Source Humanized
Target CALCA, CALCB
Clinical data
Trade names Emgality
Other namesLY2951742, galcanezumab-gnlm
AHFS/Drugs.com Monograph
MedlinePlus a618063
License data
Routes of
administration 		Subcutaneous
Drug class Calcitonin gene-related peptide receptor antagonist
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem SID
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
Formula C6392H9854N1686O2018S46
Molar mass 144083.69 g·mol−1

Galcanezumab, [4] [5] sold under the brand name Emgality, is a humanized monoclonal antibody used for the prevention of migraine. [2] It is also used for the treatment of cluster headaches. [6]

Contents

A substance called calcitonin gene-related peptide (CGRP) has been shown to be involved in the development of migraine by widening blood vessels in the brain. [3] Galcanezumab is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size. [3] This will stop the symptoms of migraine. [3] Galcanezumab is generally delivered through self-injections. [7] Common side effects include injection site reactions such as pain or redness. [6] [3] Other side effects may include hypersensitivity reactions. [6]

Galcanezumab was developed by Eli Lilly. [8] It was approved for medical use in the United States and in the European Union in 2018, [9] [10] [3] becoming the third calcitonin gene-related peptide (CGRP) inhibitor to be approved by the US Food and Drug Administration (FDA). [11]

Medical uses

In the US, galcanezumab is indicated in adults for the preventive treatment of migraine; and for the treatment of episodic cluster headache. [2]

In the EU, galcanezumab is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. [3]

Side effects

Common side effects include injection site reactions such as pain or redness, rarely hypersensitivity reactions. [6]

Pharmacology

Mechanism of action

Calcitonin gene-related peptide (CGRP) has been shown to be involved in the development of migraine by widening blood vessels in the brain. [3] Galcanezumab is a monoclonal antibody which attaches to and blocks CGRP, thereby helping blood vessels to return to their normal size. [3]

History

Clinical trials

The US Food and Drug Administration (FDA) approved galcanezumab based on evidence from three clinical trials (Trial 1/NCT02614183, Trial 2/NCT02614196, and Trial 3/NCT02614261) in 2156 adults 18 to 65 years of age with chronic or episodic migraine headaches. [10] Trials were conducted at 318 sites in Asia, Canada, Europe, Israel, Latin America, Puerto Rico, and the United States. [10]

Trials one and two enrolled participants with a history of episodic migraine headaches. [10] Participants were assigned to receive galcanezumab or placebo injections once a month for six months. [10] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed. [10] The benefit of galcanezumab was assessed based on the change from baseline in the number of migraine days per month during the six-month treatment period, comparing participants in the galcanezumab and placebo groups. [10] In two studies involving 1,784 participants who had migraines between 4 and 14 days a month, those treated with galcanezumab had four or five fewer days with migraines per month, compared with two to three fewer days for participants on a placebo injection. [3]

Trial three enrolled participants with a history of chronic migraine headaches. [10] Participants were assigned to receive galcanezumab or placebo injection once a month for three months. [10] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed. [10] The benefit of galcanezumab was assessed based on the change from baseline in the number of migraine days per month during the three-month treatment period, comparing the galcanezumab and placebo groups. [10] In a third study of 1,117 participants who had migraines for more than fifteen days a month on average (chronic migraine), those treated with galcanezumab had on average around five fewer days with migraines per month compared with around three fewer days for participants on placebo. [3]

The effectiveness of galcanezumab for the treatment of episodic cluster headache was demonstrated in a clinical trial that compared it to placebo in 106 participants. [6] The trial measured the average number of cluster headaches per week for three weeks and compared the average changes from baseline in the galcanezumab and placebo groups. [6] During the three-week period, participants taking galcanezumab experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared to 5.2 fewer attacks for participants on placebo. [6]

Society and culture

Economics

When used for migraines galcanezumab costs about US$7,000 per year in the United States as of 2019. [12]

In September 2018, galcanezumab was approved in the United States for the preventive treatment of migraine in adults. [9] [10] The FDA granted the approval of Emgality to Eli Lilly. [9] [10]

In November 2018, galcanezumab was approved for use in the European Union for the prophylaxis of migraine in adults who have at least four migraine days per month. [3]

In June 2019, galcanezumab was approved in the United States for the treatment of episodic cluster headache in adults. [6] The application for galcanezumab was granted priority review and breakthrough therapy designations. [6]

In January 2021, AffaMed Therapeutics signed an agreement with Lilly to distribute galcenazumab in China. [13] In December 2023, Organon signed an exclusive agreement with Lilly to distribute and commercialize galcanezumab in Europe. [14] In August 2024, the agreement between Organon and Lilly was expanded to include a further 11 worldwide markets. [15]

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References

  1. ↑ "Summary Basis of Decision (SBD) for Emgality". Health Canada . 23 October 2014. Retrieved 29 May 2022.
  2. 1 2 3 "Emgality- galcanezumab-gnlm injection, solution". DailyMed. 11 March 2021. Retrieved 29 April 2024.
  3. 1 2 3 4 5 6 7 8 9 10 11 12 "Emgality EPAR". European Medicines Agency (EMA). 24 September 2018. Retrieved 28 April 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  4. ↑ "Statement on a Nonproprietary Name Adopted by the USAN Council - Galcanezumab", American Medical Association.
  5. ↑ World Health Organization (2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76". WHO Drug Information. 30 (3). hdl: 10665/331020 .
  6. 1 2 3 4 5 6 7 8 9 "FDA approves first treatment for episodic cluster headache that reduces the frequency of attacks" (Press release). U.S. Food and Drug Administration (FDA). 4 June 2019. Archived from the original on 7 December 2019. Retrieved 6 June 2019.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  7. ↑ "Galcanezumab-gnlm Injection: MedlinePlus Drug Information". medlineplus.gov. Retrieved 26 July 2024.
  8. ↑ Spreitzer H (3 July 2017). "Neue Wirkstoffe: Galcanezumab, Fremanezumab und Eptinezumab". Österreichische Apothekerzeitung (in German) (14/2017).
  9. 1 2 3 "Drug Approval Package: Emgality (galcanezumab-gnlm)". U.S. Food and Drug Administration (FDA). 27 September 2018. Archived from the original on 7 December 2019. Retrieved 7 December 2019.
  10. 1 2 3 4 5 6 7 8 9 10 11 12 13 "Drug Trials Snapshots: Emgality". U.S. Food and Drug Administration (FDA). 23 October 2018. Archived from the original on 7 December 2019. Retrieved 7 December 2019.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  11. ↑ "US FDA approves Lilly migraine drug at a price that is the same as its rivals". CNBC. Reuters. 28 September 2018. Retrieved 29 September 2018.
  12. ↑ Erman M (4 June 2019). "FDA approves Lilly's migraine drug as first ever cluster headache treatment". Reuters. Retrieved 28 April 2020.
  13. ↑ "AffaMed signs deal for Lilly's Galcanezumab in Mainland China". Pharmaceutical Technology. 18 January 2023. Retrieved 26 July 2024.
  14. ↑ "Organon & Lilly Enter Commercialization Agreement in Europe for Two Migraine Medicines". Organon. Retrieved 22 August 2024.
  15. ↑ "Organon & Lilly Expand Migraine Commercialization Agreement to 11 Additional Markets". Organon. Retrieved 22 August 2024.
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