Emgality
Authorised
This medicine is authorised for use in the European Union
galcanezumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Emgality is a medicine used to prevent migraine in adults who have migraines at least 4 days a month. It contains the active substance galcanezumab.
Emgality is injected under the skin using a pre-filled syringe or pen. Patients can inject the medicine themselves after being trained.
Treatment should be started with the injection of the content of 2 syringes (or pens), followed a month later by single injections given every month. Doctors should review treatment after 3 months and only continue it if patients benefit from it.
Emgality can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of migraine. For more information about using Emgality, see the package leaflet or contact your doctor or pharmacist.
A substance called CGRP has been shown to be involved in the development of migraine by widening blood vessels in the brain. The active substance of Emgality, galcanezumab, is a monoclonal antibody (a type of protein) designed to attach to and block CGRP, thereby helping blood vessels to return to their normal size. This will stop the symptoms of migraine.
Emgality was shown to be effective at reducing the number of days patients suffer migraines in 3 main studies. Overall, Emgality led to 2 fewer days with migraines per month compared with placebo (a dummy treatment).
In two studies involving 1,784 patients who had migraines between 4 and 14 days a month, those treated with Emgality had 4 or 5 fewer days with migraines per month, compared with 2 to 3 fewer days for patients on a placebo injection.
In a third study of 1,117 patients who had migraines for more than 15 days a month on average (chronic migraine), those treated with Emgality had on average around 5 fewer days with migraines per month compared with around 3 fewer days for patients on placebo.
The most common side effects with Emgality (which may affect more than 1 in 10 people) are reactions at the site of injection such as pain, redness, itching, bruising or swelling.
For the full list of side effects and restrictions of Emgality, see the package leaflet.
Emgality was shown to be more effective than placebo at reducing the number of days of migraine, although the size of the effect is limited particularly for patients with chronic migraine.
The side effects seen with Emgality are considered manageable with most being mild or moderate in severity.
The European Medicines Agency therefore decided that Emgality’s benefits are greater than its risks and it can be authorised for use in the EU.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Emgality have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Emgality are continuously monitored. Side effects reported with Emgality are carefully evaluated and any necessary action taken to protect patients.
Emgality received a marketing authorisation valid throughout the EU on 14 November 2018.
Product information
Latest procedure affecting product information:
N/0029
25/03/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Emgality
- Active substance
- Galcanezumab
- International non-proprietary name (INN) or common name
- galcanezumab
- Therapeutic area (MeSH)
- Migraine Disorders
- Anatomical therapeutic chemical (ATC) code
- N02
Pharmacotherapeutic group
- Analgesics
- galcanezumab
Therapeutic indication
Emgality is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
Assessment history
News on Emgality
Topics
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