Galcanezumab,[4][5]sold under the brand nameEmgality,is ahumanizedmonoclonal antibodyused for the prevention ofmigraine.[2]It is also used for the treatment ofcluster headaches.[6]
 | |
| Monoclonal antibody | |
|---|---|
| Type | Whole antibody |
| Source | Humanized |
| Target | CALCA,CALCB |
| Clinical data | |
| Trade names | Emgality |
| Other names | LY2951742, galcanezumab-gnlm |
| AHFS/Drugs | 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 | |
| PubChemSID | |
| DrugBank | |
| ChemSpider |
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| UNII | |
| KEGG | |
| Chemical and physical data | |
| Formula | C6392H9854N1686O2018S46 |
| Molar mass | 144083.69g·mol−1 |
A substance calledcalcitonin 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 includeinjection site reactionssuch as pain or redness.[6][3]Other side effects may includehypersensitivity reactions.[6]
Galcanezumab was developed byEli Lilly.[8]It was approved for medical use in the United States and in the European Union in 2018,[9][10][3]becoming the thirdcalcitonin gene-related peptide(CGRP) inhibitor to be approved by the USFood and Drug Administration(FDA).[11]
Medical uses
editIn the US, galcanezumab isindicatedin 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
editCommon side effects includeinjection site reactionssuch as pain or redness, rarelyhypersensitivity reactions.[6]
Pharmacology
editMechanism of action
editCalcitonin gene-related peptide(CGRP) has been shown to be involved in the development ofmigraineby widening blood vessels in the brain.[3]Galcanezumab is amonoclonal antibodywhich attaches to and blocks CGRP, thereby helping blood vessels to return to their normal size.[3]
History
editClinical trials
editThe USFood 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
editEconomics
editWhen used for migraines galcanezumab costs aboutUS$7,000per year in the United States as of 2019[update].[12]
Legal status
editIn 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 episodiccluster headachein adults.[6]The application for galcanezumab was grantedpriority reviewandbreakthrough therapydesignations.[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]
References
edit- ^"Summary Basis of Decision (SBD) for Emgality".Health Canada.23 October 2014.Retrieved29 May2022.
- ^abc"Emgality- galcanezumab-gnlm injection, solution".DailyMed.11 March 2021.Retrieved29 April2024.
- ^abcdefghijkl"Emgality EPAR".European Medicines Agency(EMA).24 September 2018.Retrieved28 April2020.Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ^"Statement on a Nonproprietary Name Adopted by the USAN Council - Galcanezumab",American Medical Association.
- ^World Health Organization(2016). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76".WHO Drug Information.30(3).hdl:10665/331020.
- ^abcdefghi"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.Archivedfrom the original on 7 December 2019.Retrieved6 June2019.
This article incorporates text from this source, which is in thepublic domain.
- ^"Galcanezumab-gnlm Injection: MedlinePlus Drug Information".medlineplus.gov.Retrieved26 July2024.
- ^Spreitzer H (3 July 2017). "Neue Wirkstoffe: Galcanezumab, Fremanezumab und Eptinezumab".Österreichische Apothekerzeitung(in German) (14/2017).
- ^abc"Drug Approval Package: Emgality (galcanezumab-gnlm)".U.S.Food and Drug Administration(FDA). 27 September 2018. Archived fromthe originalon 7 December 2019.Retrieved7 December2019.
- ^abcdefghijklm"Drug Trials Snapshots: Emgality".U.S.Food and Drug Administration(FDA). 23 October 2018.Archivedfrom the original on 7 December 2019.Retrieved7 December2019.This article incorporates text from this source, which is in thepublic domain.
- ^"US FDA approves Lilly migraine drug at a price that is the same as its rivals".CNBC. Reuters. 28 September 2018.Retrieved29 September2018.
- ^Erman M (4 June 2019)."FDA approves Lilly's migraine drug as first ever cluster headache treatment".Reuters.Retrieved28 April2020.
- ^"AffaMed signs deal for Lilly's Galcanezumab in Mainland China".Pharmaceutical Technology.18 January 2023.Retrieved26 July2024.
- ^"Organon & Lilly Enter Commercialization Agreement in Europe for Two Migraine Medicines".Organon.Retrieved22 August2024.
- ^"Organon & Lilly Expand Migraine Commercialization Agreement to 11 Additional Markets".Organon.Retrieved22 August2024.
