Chemistry:Galcanezumab
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| Monoclonal antibody | |
|---|---|
| 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 injection |
| Drug class | Calcitonin gene-related peptide (CGRP) antagonists |
| 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, 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]
Common side effects include pain or redness at the site of injection.[4][5] Other side effects may include hypersensitivity reactions.[4] 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]
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 do so.[9] When used for migraines it costs about US$7,000 per year in the United States (As of 2019).[10]
History
In September 2018, galcanezumab-gnlm was approved in the United States for the preventive treatment of migraine in adults.[8]
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]
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 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]
Galcanezumab was shown to be effective at reducing the number of days participants had migraines in three main studies.[5] Overall, galcanezumab led to two fewer days with migraines per month compared with placebo (a dummy treatment).[5] 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] 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]
In June 2019, galcanezumab-gnlm was approved in the United States for the treatment of episodic cluster headache in adults.[4]
The effectiveness of galcanezumab-gnlm for the treatment of episodic cluster headache was demonstrated in a clinical trial that compared the drug 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]
References
- ↑ "Summary Basis of Decision (SBD) for Emgality". 23 October 2014. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00454&lang=en.
- ↑ "Statement on a Nonproprietary Name Adopted by the USAN Council - Galcanezumab", American Medical Association.
- ↑ World Health Organization (2015). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 114". WHO Drug Information 29 (4). https://www.who.int/medicines/publications/druginformation/innlists/PL114.pdf.
- ↑ 4.0 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 "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.
This article incorporates text from this source, which is in the public domain.
- ↑ 5.0 5.1 5.2 5.3 5.4 5.5 5.6 5.7 5.8 5.9 "Emgality EPAR". 24 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/emgality. This article incorporates text from this source, which is in the public domain.
- ↑ "Neue Wirkstoffe: Galcanezumab, Fremanezumab und Eptinezumab" (in German). Österreichische Apothekerzeitung (14/2017). 3 July 2017.
- ↑ "Drug Approval Package: Emgality (galcanezumab-gnlm)". U.S. Food and Drug Administration (FDA). 27 September 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/761063Orig1s000TOC.cfm.
- ↑ 8.00 8.01 8.02 8.03 8.04 8.05 8.06 8.07 8.08 8.09 8.10 8.11 "Drug Trials Snapshots: Emgality". U.S. Food and Drug Administration (FDA). 23 October 2018. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots-emgality. This article incorporates text from this source, which is in the public domain.
- ↑ "US FDA approves Lilly migraine drug at a price that is the same as its rivals". Reuters. CNBC. 28 September 2018. https://www.cnbc.com/2018/09/28/us-fda-approves-lilly-migraine-drug-at-a-price-that-is-the-same-as-its-rivals.html.
- ↑ Erman, Michael (4 June 2019). "FDA approves Lilly's migraine drug as first ever cluster headache treatment". Reuters. https://www.reuters.com/article/us-lilly-emgality-approval-idUSKCN1T52VP.
External links
- "Galcanezumab". Drug Information Portal. U.S. National Library of Medicine. https://druginfo.nlm.nih.gov/drugportal/name/galcanezumab.
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