Galcanezumab
Monoclonal antibody
TypeWhole antibody
SourceHumanized
TargetCALCA, CALCB
Clinical data
Trade namesEmgality
Other namesLY2951742, galcanezumab-gnlm
AHFS/Drugs.comMonograph
MedlinePlusa618063
License data
Routes of
administration
Subcutaneous injection
Drug classCalcitonin gene-related peptide (CGRP) antagonists
ATC code
Legal status
Legal status
  • US: ℞-only
  • EU: Rx-only
  • In general: ℞ (Prescription only)
Identifiers
CAS Number
  • 1578199-75-3
PubChem SID
DrugBank
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
FormulaC6392H9854N1686O2018S46
Molar mass144083.69 g·mol−1

Galcanezumab, sold under the brand name Emgality, is a humanized monoclonal antibody used for the prevention of migraine.[1][2] It is also used for cluster headaches.[3]

Common side effects include pain or redness at the site of injection.[3][4] Other side effects may include hypersensitivity reactions.[3] 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.[4] 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.[4] This will stop the symptoms of migraine.[4]

This drug was developed by Eli Lilly.[5] It was approved for medical use in the United States and in the European Union in 2018,[6][7][4] becoming the third calcitonin gene-related peptide (CGRP) inhibitor to do so.[8] When used for migraines it costs about US$7,000 per year in the United States as of 2019.[9]

History

In September 2018, galcanezumab-gnlm was approved in the United States for the preventive treatment of migraine in adults.[7]

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.[7] Trials were conducted at 318 sites in Asia, Canada, Europe, Israel, Latin America, Puerto Rico, and the United States.[7]

Trials one and two enrolled patients with a history of episodic migraine headaches.[7] Patients were assigned to receive galcanezumab-gnlm or placebo injections once a month for six months.[7] Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.[7] 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.[7]

Trial three enrolled patients with a history of chronic migraine headaches.[7] Patients were assigned to receive galcanezumab-gnlm or placebo injection once a month for three months.[7] Neither the patients nor the health care providers knew which treatment was being given until after the trial was completed.[7] 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.[7]

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.[4]

Galcanezumab was shown to be effective at reducing the number of days participants suffer migraines in three main studies.[4] Overall, galcanezumab led to two fewer days with migraines per month compared with placebo (a dummy treatment).[4] 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.[4] 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.[4]

In June 2019, galcanezumab-gnlm was approved in the United States for the treatment of episodic cluster headache in adults.[3]

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.[3] 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.[3] 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.[3]

The application for galcanezumab-gnlm was granted priority review designation and breakthrough therapy designation.[3] The FDA granted the approval of Emgality to Eli Lilly[3]

See also

References

  1. ^ "Statement on a Nonproprietary Name Adopted by the USAN Council - Galcanezumab", American Medical Association.
  2. ^ World Health Organization (2015). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 114" (PDF). WHO Drug Information. 29 (4).
  3. ^ a b c d e f g h i "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.
  4. ^ a b c d e f g h i j "Emgality EPAR". European Medicines Agency (EMA). Retrieved 28 April 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  5. ^ Spreitzer H (3 July 2017). "Neue Wirkstoffe: Galcanezumab, Fremanezumab und Eptinezumab". Österreichische Apothekerzeitung (in German) (14/2017).
  6. ^ "Drug Approval Package: Emgality (galcanezumab-gnlm)". U.S. Food and Drug Administration (FDA). 27 September 2018. Archived from the original on 7 December 2019. Retrieved 7 December 2019.
  7. ^ a b c d e f g h i j k l "Drug Trials Snapshots: Emgality". U.S. Food and Drug Administration (FDA). 23 October 2018. Archived from the original on 7 December 2019. Retrieved 7 December 2019. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ "US FDA approves Lilly migraine drug at a price that is the same as its rivals". CNBC. Reuters. 28 September 2018. Retrieved 29 September 2018.
  9. ^ Erman, Michael (4 June 2019). "FDA approves Lilly's migraine drug as first ever cluster headache treatment". Reuters. Retrieved 28 April 2020.