Basic Information
N02CD01
erenumab
Analgesics
Therapeutic indication
Aimovig is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month when initiating treatment with Aimovig.
Overview Summary
Aimovig is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Aimovig contains the active substance erenumab.
Active Substances (2)
erenumab
erenumab
Documents (13)
Aimovig : EPAR - Public assessment report
August 7, 2018
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Aimovig : EPAR - Product Information
August 7, 2018
DRUG_PRODUCT_INFORMATION
Aimovig : EPAR - Procedural steps taken and scientific information after authorisation
May 6, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Aimovig-H-C-PSUSA-00010699-201911 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
September 9, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Aimovig : EPAR - Risk-management-plan summary
August 7, 2018
RISK_MANAGEMENT_PLAN_SUMMARY
Aimovig-H-C-4447-X-0001 : EPAR - Assessment report
May 6, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Aimovig-H-C-PSUSA-00010699-201905 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
February 21, 2020
CHANGES_SINCE_INITIAL_AUTHORISATION
Aimovig : EPAR - Summary for the public
August 7, 2018
OVERVIEW_DOCUMENT
Aimovig : EPAR - All Authorised presentations
August 7, 2018
AUTHORISED_PRESENTATIONS
CHMP summary of positive opinion for Aimovig
June 1, 2018
INITIAL_MARKETING_AUTHORISATION_DOCUMENTS
Aimovig-H-C-PSUSA-00010699-201811 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation
September 20, 2019
CHANGES_SINCE_INITIAL_AUTHORISATION
Aimovig : EPAR - Public assessment report
August 7, 2018
CHANGES_SINCE_INITIAL_AUTHORISATION
CHMP summary of positive opinion for Aimovig
June 1, 2018
CHANGES_SINCE_INITIAL_AUTHORISATION
Overview Q&A (7)
Question
How is Aimovig used?
Answer
Aimovig is injected under the skin using a pre-filled syringe or pen. Patients can inject the medicine themselves after being trained.
The recommended dose is 70 mg every 4 weeks as a single injection. Some patients may benefit from a dose of 140 mg every 4 weeks, given as either a single injection of 140 mg or two injections of 70 mg.
Aimovig can only be obtained with a prescription and treatment should be started by a doctor experienced in the diagnosis and treatment of migraine. For more information about using Aimovig, see the package leaflet or contact your doctor or pharmacist.
Question
How does Aimovig work?
Answer
A chemical messenger called CGRP has been shown to be involved in the development of migraine. The active substance in Aimovig, erenumab, is a monoclonal antibody (a type of protein) designed to attach to a receptor (target) for CGRP on body’s cells. By attaching to this receptor, the medicine stops CGRP from attaching to it and causing migraine.
Question
What benefits of Aimovig have been shown in studies?
Answer
Aimovig is effective at reducing the number of days patients suffer migraines. In a study of 667 patients who had migraines 18 days a month on average, those treated with Aimovig had 7 fewer days with migraines per month, compared with 4 fewer days for patients on placebo.
In a second study of 955 patients who had migraines 8 days a month on average, those treated with Aimovig had on average 3 to 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo.
Question
What are the risks associated with Aimovig?
Answer
The most common side effects with Aimovig (which may affect up to 1 in 10 people) are reactions at the site of injection, constipation, muscle spasms and itching.
For the full list of side effects and restrictions of Aimovig, see the package leaflet.
Question
Why is Aimovig authorised in the EU?
Answer
Aimovig was shown to be effective at reducing the number of days patients have migraines. Only patients with migraines at least 4 days a month were included in the studies as patients with less frequent migraines are not usually eligible for preventative treatment.
Most of the side effects are mild or moderate in severity. The European Medicines Agency therefore decided that Aimovig’s benefits are greater than its risks and it can be authorised for use in the EU.
Question
What measures are being taken to ensure the safe and effective use of Aimovig?
Answer
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aimovig have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Aimovig are continuously monitored. Side effects reported with Aimovig are carefully evaluated and any necessary action taken to protect patients.
Question
Other information about Aimovig
Answer
Aimovig received a marketing authorisation valid throughout the EU on 26 July 2018.