Vyepti
Authorised
This medicine is authorised for use in the European Union
eptinezumab
MedicineHumanAuthorised
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Vyepti is a medicine used to prevent migraine in adults who have migraines at least 4 days a month.
Vyepti contains the active substance eptinezumab.
The medicine can only be obtained with a prescription. Treatment should be started and monitored by healthcare professionals experienced in the diagnosis and treatment of migraine.
Vyepti is given by infusion (drip) into a vein over 30 minutes once every 12 weeks. The recommended dose is 100 mg. This dose may be increased to 300 mg, depending on how the patient responds.
For more information about using Vyepti, see the package leaflet or contact your doctor or pharmacist.
A substance in the body called calcitonin gene-related peptide (CGRP) contributes to the development of migraine. The active substance in Vyepti, eptinezumab, 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.
Two main studies showed that Vyepti is effective at reducing the number of days patients suffer from migraines.
The first was a 48-week study involving 898 adults who had at least 4 migraine days a month and between 4 to 14 headache days a month. Those treated with 100 mg or 300 mg Vyepti had around 4 fewer days with migraines per month during the first 12 weeks of treatment, compared with 3 fewer days for patients on placebo (dummy treatment).
The second was a 24-week study involving 1,121 adults who had migraines for at least 8 days a month and between 15 and 26 headache days a month. Those treated with 100 mg or 300 mg Vyepti had on average 8 fewer days with migraines per month during the first 12 weeks of treatment compared with around 6 fewer days for patients on placebo.
The most common side effects with Vyepti (which may affect up to 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat), hypersensitivity (allergic) reactions and tiredness.
For the full list of side effects of Vyepti, see the package leaflet.
The European Medicines Agency decided that Vyepti’s benefits are greater than its risks and it can be authorised for use in the EU. Two main studies have shown that Vyepti is effective at reducing the number of days patients suffer from migraines. The side effects are considered manageable.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vyepti have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Vyepti are continuously monitored. Suspected side effects reported with Vyepti are carefully evaluated and any necessary action taken to protect patients.
Vyepti received a marketing authorisation valid throughout the EU on 24 January 2022.
Product information
Latest procedure affecting product information:
II/0020
12/09/2024
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
- Vyepti
- Active substance
- Eptinezumab
- International non-proprietary name (INN) or common name
- eptinezumab
- Therapeutic area (MeSH)
- Migraine Disorders
- Anatomical therapeutic chemical (ATC) code
- N02CD
Pharmacotherapeutic group
AnalgesicsTherapeutic indication
Vyepti is indicated for the prophylaxis of migraine in adults who have at least 4 migraine days per month.
News on Vyepti
This page was last updated on