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Galcanezumab
Monoclonal antibody From Wikipedia, the free encyclopedia
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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]
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]
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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
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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]
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Society and culture
Economics
When used for migraines galcanezumab costs about US$7,000 per year in the United States as of 2019[update].[12]
Legal status
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
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