MedPath
EMA Approval

Ajovy

N02CD03

fremanezumab

Calcitonin gene-related peptide (CGRP) antagonists

fremanezumab

Migraine Disorders

Basic Information

N02CD03

fremanezumab

Calcitonin gene-related peptide (CGRP) antagonists

Therapeutic indication

Ajovy is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month.

Overview Summary

Ajovy is a medicine used to prevent migraine in adults who have migraines at least 4 days a month. The active substance contained in Ajovy is fremanezumab.

Authorisations (1)

EMEA/H/C/004833

Teva GmbH,Graf-Arco-Straße 3,D-89079 Ulm,Germany

Authorised

March 28, 2019

Active Substances (2)

fremanezumab

fremanezumab

Documents (11)

Ajovy : EPAR - Medicine overview

April 17, 2019

OVERVIEW_DOCUMENT

CHMP summary of positive opinion for Ajovy

February 1, 2019

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Ajovy-H-C-PSUSA-00010758-202103 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

March 29, 2022

CHANGES_SINCE_INITIAL_AUTHORISATION

Ajovy : EPAR - Public assessment report

April 17, 2019

INITIAL_MARKETING_AUTHORISATION_DOCUMENTS

Ajovy : EPAR - Public assessment report

April 17, 2019

CHANGES_SINCE_INITIAL_AUTHORISATION

CHMP summary of positive opinion for Ajovy

February 1, 2019

CHANGES_SINCE_INITIAL_AUTHORISATION

Ajovy : EPAR - Risk management plan

April 17, 2019

RISK_MANAGEMENT_PLAN_SUMMARY

Ajovy : EPAR - Procedural steps taken and scientific information after authorisation

January 20, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

Ajovy : EPAR - Product Information

April 17, 2019

DRUG_PRODUCT_INFORMATION

Ajovy : EPAR - All Authorised presentations

April 17, 2019

AUTHORISED_PRESENTATIONS

Ajovy- H-C-PSUSA-00010758-202003: EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation

August 6, 2020

CHANGES_SINCE_INITIAL_AUTHORISATION

Overview Q&A (7)

Question

How is Ajovy used?

Answer

Ajovy is injected under the skin using a pre-filled syringe. Patients can inject the medicine themselves after being trained.

The recommended dose is either 225 mg every month or 675 mg every three months. For the 675 mg dose, three injections of 225 mg have to be injected one after another, each in a different place.

Ajovy 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 Ajovy, see the package leaflet or contact your doctor or pharmacist.

Question

How does Ajovy work?

Answer

A chemical messenger called CGRP contributes to the development of migraine. Ajovy is a monoclonal antibody (a type of protein) designed to attach to CGRP and prevent it from binding to its target on the body’s cells thereby helping to prevent migraines from occurring.

Question

What benefits of Ajovy have been shown in studies?

Answer

Ajovy was shown to reduce the number of days patients have moderate to severe headaches and migraines in 2 main studies.

In a study of 1,130 patients who had moderate to severe headaches 13 days a month on average, those treated with Ajovy had between 4 and 5 fewer days with moderate to severe headaches per month compared with 2 to 3 fewer days for patients on placebo (a dummy treatment), during the 12 week-study.

In a study with 875 patients who had migraines 9 days a month on average, those treated with Ajovy had between 3 and 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo, during the 12 week-study.

Question

What are the risks associated with Ajovy?

Answer

The most common side effects with Ajovy (which may affect more than 1 in 10 people) are reactions at the site of injection: pain, hardening (induration) and reddening of the skin (erythema).

For the full list of side effects and restrictions of Ajovy, see the package leaflet.

Question

Why is Ajovy authorised in the EU?

Answer

Ajovy can reduce the number of days patients have moderate to severe headaches and migraines. As most of the side effects are manageable and mild or moderate in severity, the European Medicines Agency decided that Ajovy’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 Ajovy?

Answer

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Ajovy have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Ajovy are continuously monitored. Side effects reported with Ajovy are carefully evaluated and any necessary action taken to protect patients.

Question

Other information about Ajovy

Answer

Ajovy received a marketing authorisation valid throughout the EU on 28/03/2019.

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