MedPath
EMA Approval

Aimovig

N02CD01

erenumab

Analgesics

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.

Authorisations (1)

EMEA/H/C/004447

Novartis Europharm Limited,Vista Building,Elm Park, Merrion Road,Dublin 4,Ireland

Authorised

July 26, 2018

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.

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