Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized |
Target | CALCA, CALCB |
Clinical data | |
Trade names | Emgality |
Other names | LY2951742, galcanezumab-gnlm |
AHFS/ Drugs.com | Monograph |
MedlinePlus | a618063 |
License data |
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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 |
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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]
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] 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. [7] It was approved for medical use in the United States and in the European Union in 2018, [8] [9] [3] becoming the third calcitonin gene-related peptide (CGRP) inhibitor to be approved by the US Food and Drug Administration (FDA). [10]
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]
Common side effects include injection site reactions such as pain or redness, rarely hypersensitivity reactions. [6]
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]
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. [9] Trials were conducted at 318 sites in Asia, Canada, Europe, Israel, Latin America, Puerto Rico, and the United States. [9]
Trials one and two enrolled participants with a history of episodic migraine headaches. [9] Participants were assigned to receive galcanezumab or placebo injections once a month for six months. [9] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed. [9] 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. [9] 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. [9] Participants were assigned to receive galcanezumab or placebo injection once a month for three months. [9] Neither the participants nor the health care providers knew which treatment was being given until after the trial was completed. [9] 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. [9] 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]
When used for migraines galcanezumab costs about US$7,000 per year in the United States as of 2019 [update]. [11]
In September 2018, galcanezumab was approved in the United States for the preventive treatment of migraine in adults. [8] [9] The FDA granted the approval of Emgality to Eli Lilly. [8] [9]
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]