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.
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.