Lacosamide Adroiq

Authorised

This medicine is authorised for use in the European Union

lacosamide

Overview

Lacosamide Adroiq is a medicine used on its own or as an add-on to other epilepsy medicines in the treatment of partial-onset seizures (epileptic fits starting in one specific part of the brain) with or without secondary generalisation (where the abnormal electrical activity spreads through the brain) in patients with epilepsy aged 2 years and older.

Lacosamide Adroiq can also be used as add-on to other epilepsy medicines in the treatment of primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 4 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).

Lacosamide Adroiq is a ‘generic medicine’. This means that Lacosamide Adroiq contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU. The reference medicine for Lacosamide Adroiq is Vimpat. For more information on generic medicines, see the question-and-answer document here.

Lacosamide Adroiq contains the active substance lacosamide.

How is Lacosamide Adroiq used?

Lacosamide Adroiq is available as a solution for infusion (drip) into a vein and is given twice a day.

The medicine can only be obtained with a prescription.

For more information about using Lacosamide Adroiq, see the package leaflet or contact your doctor or pharmacist.

How does Lacosamide Adroiq work?

The active substance in Lacosamide Adroiq, lacosamide, is an epilepsy medicine. Epilepsy is caused by abnormal electrical activity in the brain. The exact way in which lacosamide works is unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells. This action may prevent abnormal electrical activity in the brain, reducing the chance of an epileptic fit.

How has Lacosamide Adroiq been studied?

Studies on the benefits and risks of the active substance in the authorised uses have already been carried out with the reference medicine, Vimpat, and do not need to be repeated for Lacosamide Adroiq.

As for every medicine, the company provided studies on the quality of Lacosamide Adroiq. There was no need for ‘bioequivalence’ studies to investigate whether Lacosamide Adroiq is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood. This is because Lacosamide Adroiq is given by infusion into a vein, so the active substance is delivered straight into the bloodstream.

What are the benefits and risks of Lacosamide Adroiq?

Because Lacosamide Adroiq is a generic medicine, its benefits and risks are taken as being the same as the reference medicine’s.

For the list of side effects and restrictions with Lacosamide Adroiq, see the package leaflet.

Why is Lacosamide Adroiq authorised in the EU?

The European Medicines Agency concluded that, in accordance with EU requirements, Lacosamide Adroiq has been shown to be comparable to Vimpat. Therefore, the Agency’s view was that, as for Vimpat, the benefits of Lacosamide Adroiq outweigh the identified risks and it can be authorised for use in the EU.

What measures are being taken to ensure the safe and effective use of Lacosamide Adroiq?

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

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

Other information about Lacosamide Adroiq

Lacosamide Adroiq received a marketing authorisation valid throughout the EU on 31 May 2023.

Lacosamide Adroiq : EPAR - Medicine Overview

Reference Number: EMA/162596/2023

Lacosamide Adroiq : EPAR - Risk management plan summary

Product information

Lacosamide Adroiq : EPAR - Product Information

Lacosamide Adroiq : EPAR - All authorised presentations

Product details

• Name of medicine:
  Lacosamide Adroiq
• Active substance:
  lacosamide
• International non-proprietary name (INN) or common name:
  lacosamide
• Therapeutic area (MeSH):
  Epilepsy
• Anatomical therapeutic chemical (ATC) code:
  N03AX18

Pharmacotherapeutic group

Antiepileptics

Therapeutic indication

Lacosamide Adroiq is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.

Lacosamide Adroiq is indicated as adjunctive therapy

• in the treatment of partial-onset seizures with or without secondary generalisation in adults, adolescents and children from 2 years of age with epilepsy.
• in the treatment of primary generalised tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalised epilepsy.

Authorisation details

• EMA product number:
  EMEA/H/C/006047
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  Extrovis EU Ltd.

  Patriarka utca 14; 2000 Szentendre; Hungary

• Opinion adopted:
  30/03/2023
• Marketing authorisation issued:
  31/05/2023
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

Lacosamide Adroiq : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Lacosamide Adroiq : EPAR - Public Assessment Report

AdoptedReference Number: EMA/216528/2023

CHMP summary of positive opinion for Lacosamide Adroiq

AdoptedReference Number: EMA/CHMP/126756/2023