Chemistry:Galcanezumab

From HandWiki

Galcanezumab,[1][2] sold under the brand name Emgality, is a humanized monoclonal antibody used for the prevention of migraine.[3] It is also used for the treatment of cluster headaches.[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] Galcanezumab is generally delivered through self-injections.[6] Common side effects include injection site reactions such as pain or redness.[4][5] Other side effects may include hypersensitivity reactions.[4]

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][5] becoming the third calcitonin gene-related peptide (CGRP) inhibitor to be approved by the US Food and Drug Administration (FDA).[10]

Medical uses

In the US, galcanezumab is indicated in adults for the preventive treatment of migraine; and for the treatment of episodic cluster headache.[3]

In the EU, galcanezumab is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month.[5]

Side effects

Common side effects include injection site reactions such as pain or redness, rarely hypersensitivity reactions.[4]

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.[5] Galcanezumab is a monoclonal antibody which attaches to and blocks CGRP, thereby helping blood vessels to return to their normal size.[5]

History

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.[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.[5]

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.[5]

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.[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 and placebo groups.[4] 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.[4]

Society and culture

Economics

When used for migraines galcanezumab costs about US$7,000 per year in the United States as of 2019.[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.[5]

In June 2019, galcanezumab was approved in the United States for the treatment of episodic cluster headache in adults.[4] The application for galcanezumab was granted priority review and breakthrough therapy designations.[4]

In January 2021, AffaMed Therapeutics signed an agreement with Lilly to distribute galcenazumab in China.[12] In December 2023, Organon signed an exclusive agreement with Lilly to distribute and commercialize galcanezumab in Europe.[13] In August 2024, the agreement between Organon and Lilly was expanded to include a further 11 worldwide markets.[14]

References

  1. ↑ "Statement on a Nonproprietary Name Adopted by the USAN Council - Galcanezumab", American Medical Association.
  2. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 76". WHO Drug Information 30 (3). 2016. 
  3. ↑ 3.0 3.1 Cite error: Invalid <ref> tag; no text was provided for refs named Emgality FDA label
  4. ↑ 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. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ↑ 5.00 5.01 5.02 5.03 5.04 5.05 5.06 5.07 5.08 5.09 5.10 "Emgality EPAR". 24 September 2018. https://www.ema.europa.eu/en/medicines/human/EPAR/emgality.  Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  6. ↑ "Galcanezumab-gnlm Injection: MedlinePlus Drug Information" (in en). https://medlineplus.gov/druginfo/meds/a618063.html. 
  7. ↑ "Neue Wirkstoffe: Galcanezumab, Fremanezumab und Eptinezumab" (in German). Österreichische Apothekerzeitung (14/2017). 3 July 2017. 
  8. ↑ 8.0 8.1 8.2 "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. 
  9. ↑ 9.00 9.01 9.02 9.03 9.04 9.05 9.06 9.07 9.08 9.09 9.10 9.11 9.12 "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.  Public Domain This article incorporates text from this source, which is in the public domain.
  10. ↑ "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. 
  11. ↑ 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. 
  12. ↑ "AffaMed signs deal for Lilly's Galcanezumab in Mainland China" (in en-US). 2023-01-18. https://www.pharmaceutical-technology.com/news/affamed-lilly-galcanezumab-china/. 
  13. ↑ "Organon & Lilly Enter Commercialization Agreement in Europe for Two Migraine Medicines" (in en-US). https://www.organon.com/news/organon-lilly-enter-commercialization-agreement-in-europe-for-two-migraine-medicines/. 
  14. ↑ "Organon & Lilly Expand Migraine Commercialization Agreement to 11 Additional Markets" (in en-US). https://www.organon.com/news/organon-lilly-expand-migraine-commercialization-agreement-to-11-additional-markets/. 



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