Galcanezumab, sold under the brand name Emgality, is a humanized monoclonal antibody used for the prevention of migraine.[2][3] It is also used for cluster headaches.[4]
Monoclonal antibody | |
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Type | Whole antibody |
Source | Humanized |
Target | CALCA, CALCB |
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Trade names | Emgality |
Other names | LY2951742, galcanezumab-gnlm |
AHFS/Drugs.com | Monograph |
MedlinePlus | a618063 |
License data | |
Routes of administration | Subcutaneous injection |
Drug class | Calcitonin gene-related peptide (CGRP) antagonists |
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Chemical and physical data | |
Formula | C6392H9854N1686O2018S46 |
Molar mass | 144083.69 g·mol−1 |
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.[5] 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.[5] This will stop the symptoms of migraine.[5] Common side effects include injection site reactions such as pain or redness.[4][5] Other side effects may include hypersensitivity reactions.[4]
This drug was developed by Eli Lilly.[6] It was approved for medical use in the United States and in the European Union in 2018,[7][8][5] becoming the third calcitonin gene-related peptide (CGRP) inhibitor to be approved.[9] When used for migraines it costs about US$7,000 per year in the United States as of 2019[update].[10]
Calcitonin gene-related peptide (CGRP) has been shown to be involved in the development of migraine by widening blood vessels in the brain.[5] Galcanezumab is a monoclonal antibody which attaches to and blocks CGRP, thereby helping blood vessels to return to their normal size.[5]
Common side effects include injection site reactions such as pain or redness, rarely hypersensitivity reactions.[4]
In September 2018, galcanezumab-gnlm was approved in the United States for the preventive treatment of migraine in adults.[8] 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.[5]
In June 2019, galcanezumab-gnlm was approved in the United States for the treatment of episodic cluster headache in adults.[4]
The U.S. Food and Drug Administration (FDA) approved galcanezumab-gnlm based on evidence from three clinical trials (Trial 1/NCT02614183, Trial 2/NCT02614196, and Trial 3/NCT02614261) in 2156 adult patients 18 to 65 years of age with chronic or episodic migraine headaches.[8] Trials were conducted at 318 sites in Asia, Canada, Europe, Israel, Latin America, Puerto Rico, and the United States.[8]
Trials one and two enrolled patients with a history of episodic migraine headaches.[8] Patients were assigned to receive galcanezumab-gnlm or placebo injections once a month for six months.[8] Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.[8] The benefit of galcanezumab-gnlm was assessed based on the change from baseline in the number of migraine days per month during the six-month treatment period, comparing patients in the galcanezumab-gnlm and placebo groups.[8] 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.[5]
Trial three enrolled patients with a history of chronic migraine headaches.[8] Patients were assigned to receive galcanezumab-gnlm or placebo injection once a month for three months.[8] Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.[8] The benefit of galcanezumab-gnlm 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-gnlm and placebo groups.[8]
In a third study of 1,117 participants who had migraines for more than 15 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.[5]
The effectiveness of galcanezumab-gnlm for the treatment of episodic cluster headache was demonstrated in a clinical trial that compared it to placebo in 106 patients.[4] The trial measured the average number of cluster headaches per week for three weeks and compared the average changes from baseline in the galcanezumab-gnlm and placebo groups.[4] During the three-week period, patients taking galcanezumab-gnlm experienced 8.7 fewer weekly cluster headache attacks than they did at baseline, compared to 5.2 fewer attacks for patients on placebo.[4]
The application for galcanezumab-gnlm was granted priority review designation and breakthrough therapy designation.[4] The FDA granted the approval of Emgality to Eli Lilly.[4]