Erenumab

Erenumab
Monoclonal antibody
Type Whole antibody
Source Human
Target CGRPR
Clinical data
Trade names Aimovig
Synonyms AMG-334
ATC code
Legal status
Legal status
  • US: ℞-only
Identifiers
CAS Number
ChemSpider
  • none
UNII
KEGG
Chemical and physical data
Formula C6472H9964N1728O2018S50
Molar mass 145.9 kDa

Erenumab (trade name Aimovig) is a medication which targets the calcitonin gene-related peptide receptor (CGRPR) for the prevention of migraine.[1][2][3] It was the first of the group of CGRPR antagonists to be approved in 2018.[4]

Uses

Erenumab is approved for prevention of migraine in adults.[5]

It is administered by subcutaneous injection of 70 or 140 mg once a month.[6]

Pharmacology

Erenumab is a fully human monoclonal antibody of calcitonin gene-related peptide receptor (CGRPR).[6]

History

Development

This medication was developed by Amgen Inc.[3]

In the phase III STRIVE clinical trial 955 patients were divided into three groups in a 1:1:1 ratio. Each group was injected subcutaneously monthly with 0, 70 or 140 mg erenumab over a period of 6 months. The results were measured as mean monthly migraine days in months 4, 5, and 6. At baseline the patients experienced between 4 and 14 migraine days per month with an average of 8.3. The medication significantly reduced the number of migraine days per month by 3.2 in the 70-mg group and 3.7 in the 140-mg group, versus 1.8 in the placebo (0-mg) group.[3][7]

Approval and marketing

The United States Food and Drug Administration approved the medication for the preventive treatment of migraine in adults on May 17, 2018. The list price was reported to be US$6,900 per year.[8] It was licensed by the European Medicines Agency on July 31, 2018[9] and is being evaluated by the National Institute for Health and Care Excellence as of September 2018.[10]

See also

References

  1. Statement On A Nonproprietary Name Adopted By The USAN Council - Erenumab, American Medical Association.
  2. World Health Organization (2016). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 115" (PDF). WHO Drug Information. 30 (2).
  3. 1 2 3 Goadsby; et al. (2017). "A Controlled Trial of Erenumab for Episodic Migraine". N. Engl. J. Med. (377:2123–2132).
  4. "FDA Approves First-in-Class Drug Erenumab (Aimovig) for Migraine Prevention". www.medscape.com.
  5. "Medscape Log In". www.medscape.com.
  6. 1 2 "Aimovig (erenumab-aooe) FDA Approval History - Drugs.com". Drugs.com.
  7. Erenumab to prevent migraine: results from phase III STRIBE", Pharma World, December 14, 2017.
  8. Gina Kolata (May 17, 2018), "New Drug Offers Hope to Millions With Severe Migraines", The New York Times.
  9. "First drug to prevent chronic migraines approved by EU". The Guardian. 31 July 2018. Retrieved 19 September 2018.
  10. "Erenumab for preventing migraine [ID1188] | Guidance and guidelines | NICE". www.nice.org.uk. National Institute for Health and Care Excellence. Retrieved 19 September 2018.
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.